Pharsight

1. Adempas patent expiration

Treatment: Treatment of adults with pulmonary hypertension (pah), (who group 1), to improve exercise capacity, who functional class and to delay clinical worsening

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6743798	BAYER HLTHCARE	Substituted pyrazole derivatives condensed with six-membered heterocyclic rings	Jul, 2019 (6 years ago)
US10662188	BAYER HLTHCARE	Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate	Feb, 2034 (8 years from now)
US11203593	BAYER HLTHCARE	Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate	Feb, 2034 (8 years from now)
US7173037	BAYER HLTHCARE	Carbamate-substituted pyrazolopyridines	Dec, 2026 (10 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 08, 2018
Orphan Drug Exclusivity(ODE)	Oct 08, 2020
Orphan Drug Exclusivity(ODE-53)	Oct 08, 2020

Drugs and Companies using RIOCIGUAT ingredient

NCE-1 date: 08 October, 2017

Market Authorisation Date: 08 October, 2013

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg	10 Oct, 2017	3	01 Sep, 2022	04 Dec, 2026	Deferred

Strength	Dosage	Availability
1.5MG	TABLET	Prescription
0.5MG	TABLET	Prescription
2.5MG	TABLET	Prescription
2MG	TABLET	Prescription
1MG	TABLET	Prescription

ADEMPAS family patents

2. Angiomax patent expiration

Treatment: Inhibition of thrombin in a patient

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5196404 (Pediatric)	SANDOZ	Inhibitors of thrombin	Jun, 2015 (10 years ago)
US5196404	SANDOZ	Inhibitors of thrombin	Dec, 2014 (11 years ago)
US7582727	SANDOZ	Pharmaceutical formulations of bivalirudin and processes of making the same	Jul, 2028 (2 years from now)
US7598343	SANDOZ	Pharmaceutical formulations of bivalirudin and processes of making the same	Jul, 2028 (2 years from now)
US7582727 (Pediatric)	SANDOZ	Pharmaceutical formulations of bivalirudin and processes of making the same	Jan, 2029 (3 years from now)
US7598343 (Pediatric)	SANDOZ	Pharmaceutical formulations of bivalirudin and processes of making the same	Jan, 2029 (3 years from now)

Drugs and Companies using BIVALIRUDIN ingredient

Market Authorisation Date: 15 December, 2000

Dosage: INJECTABLE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
250 mg/vial	01 Sep, 2009	1		27 Jul, 2028	Extinguished

Strength	Dosage	Availability
250MG/VIAL	INJECTABLE	Prescription

ANGIOMAX family patents

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3. Attruby patent expiration

Treatment: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (attr-cm)

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9642838	BRIDGEBIO PHARMA	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions	May, 2031 (5 years from now)
US10513497	BRIDGEBIO PHARMA	Process for preparing AG-10, its intermediates, and salts thereof	Feb, 2038 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11919865	BRIDGEBIO PHARMA	Processes for preparing AG-10, its intermediates, and salts thereof	Feb, 2038 (12 years from now)
US9169214	BRIDGEBIO PHARMA	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions	May, 2031 (5 years from now)
US9913826	BRIDGEBIO PHARMA	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions	May, 2031 (5 years from now)
US10842777	BRIDGEBIO PHARMA	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions	May, 2031 (5 years from now)
US12070449	BRIDGEBIO PHARMA	Methods of treating TTR amyloidosis using AG10	Mar, 2039 (13 years from now)
US12005043	BRIDGEBIO PHARMA	Formulations of AG10	Aug, 2039 (13 years from now)
US11058668	BRIDGEBIO PHARMA	Methods of treating TTR amyloidosis using AG10	Mar, 2039 (13 years from now)
US10398681	BRIDGEBIO PHARMA	Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions	May, 2031 (5 years from now)
US8877795	BRIDGEBIO PHARMA	Identification of stabilizers of multimeric proteins	May, 2031 (5 years from now)
US11260047	BRIDGEBIO PHARMA	Formulations of AG10	Aug, 2039 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 22, 2029
Orphan Drug Exclusivity(ODE-506)	Nov 22, 2031

Drugs and Companies using ACORAMIDIS HYDROCHLORIDE ingredient

NCE-1 date: 22 November, 2028

Market Authorisation Date: 22 November, 2024

Dosage: TABLET

Strength	Dosage	Availability
EQ 356MG BASE	TABLET	Prescription

ATTRUBY family patents

4. Benicar patent expiration

Treatment: Use as an antihypertensive agent; Treatment of hypertension

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5616599	COSETTE	Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use	Apr, 2016 (9 years ago)
US6878703	COSETTE	Pharmaceutical composition	Nov, 2021 (4 years ago)
US6878703 (Pediatric)	COSETTE	Pharmaceutical composition	May, 2022 (3 years ago)
US5616599 (Pediatric)	COSETTE	Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use	Oct, 2016 (9 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Feb 04, 2013
Pediatric Exclusivity(PED)	Aug 04, 2013

Drugs and Companies using OLMESARTAN MEDOXOMIL ingredient

Market Authorisation Date: 25 April, 2002

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg, 20 mg and 40 mg	25 Apr, 2006	1	26 Oct, 2016	19 Nov, 2021	Eligible

Strength	Dosage	Availability
20MG	TABLET	Prescription
40MG	TABLET	Prescription
5MG	TABLET	Prescription

BENICAR family patents

Treatment: Prophylaxis of pulmonary embolism; Prophylaxis of venous thromboembolism; Inhibiting coagulation; Prophylaxis of venous thrombosis; Preventing condition characterized by undesired thrombosis

Application	Filing Date	Opposition Party	Legal Status

EP07864488A	2013-11-26	Sölch, Günter	Revoked
EP07864488A	2013-11-18	Zentiva k.s.	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8691847	PORTOLA PHARMS INC	Benzamides and related inhibitors of factor Xa	Sep, 2020 (5 years ago)
US6376515	PORTOLA PHARMS INC	Benzamides and related inhibitors of factor Xa	Sep, 2020 (5 years ago)
US8518977	PORTOLA PHARMS INC	Benzamides and related inhibitors of factor XA	Sep, 2020 (5 years ago)
US6835739	PORTOLA PHARMS INC	Benzamides and related inhibitors of factor Xa	Sep, 2020 (5 years ago)
US7598276	PORTOLA PHARMS INC	Pharmaceutical salts and polymorphs of a factor Xa inhibitor	Nov, 2026 (9 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9555023	PORTOLA PHARMS INC	Pharmaceutical salts and polymorphs of a factor Xa inhibitor	Nov, 2026 (9 months from now)
US9629831	PORTOLA PHARMS INC	Benzamides and related inhibitors of factor XA	Sep, 2020 (5 years ago)
US8404724	PORTOLA PHARMS INC	Unit dose formulations and methods of treating thrombosis with an oral factor Xa inhibitor	Mar, 2031 (5 years from now)
US8557852	PORTOLA PHARMS INC	Methods of using crystalline forms of a salt of a factor Xa inhibitor	Sep, 2028 (2 years from now)
US8987463	PORTOLA PHARMS INC	Methods of synthesizing factor Xa inhibitors	Dec, 2030 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 23, 2022

Drugs and Companies using BETRIXABAN ingredient

NCE-1 date: 23 June, 2021

Market Authorisation Date: 23 June, 2017

Dosage: CAPSULE

Strength	Dosage	Availability
40MG	CAPSULE	Discontinued
80MG	CAPSULE	Discontinued

BEVYXXA family patents

6. Brenzavvy patent expiration

Treatment: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8802637	THERACOSBIO	Benzylbenzene derivatives and methods of use	Aug, 2028 (2 years from now)
US7838499	THERACOSBIO	Benzylbenzene derivatives and methods of use	Jan, 2029 (3 years from now)
US8987323	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	May, 2032 (6 years from now)
US10981942	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	Jun, 2031 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10533032	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	Jul, 2031 (5 years from now)
US8106021	THERACOSBIO	Benzylbenzene derivatives and methods of use	Aug, 2028 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 20, 2028

Drugs and Companies using BEXAGLIFLOZIN ingredient

NCE-1 date: 20 January, 2027

Market Authorisation Date: 20 January, 2023

Dosage: TABLET

Strength	Dosage	Availability
20MG	TABLET	Prescription

BRENZAVVY family patents

7. Brilinta patent expiration

Treatment: Reduction of the rate of thrombotic events in patients with acute coronary syndrome; Reducing the rate of cardiovascular death, myocardial i...

Application	Filing Date	Opposition Party	Legal Status

EP07794121A	2017-12-22	Generics [UK] Limited (trading as Mylan)	Revoked
EP07794121A	2017-12-21	Hexal Biotech GmbH	Revoked
EP07794121A	2017-12-18	Wittkopp, Alexander	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7250419	ASTRAZENECA	Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition	Dec, 2019 (6 years ago)
US7265124	ASTRAZENECA	Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound	Jul, 2021 (4 years ago)
US6525060	ASTRAZENECA	Triazolo(4,5-d)pyrimidine compounds	Dec, 2019 (6 years ago)
US6251910	ASTRAZENECA	1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists	Jul, 2018 (7 years ago)
USRE46276	ASTRAZENECA	Triazolo(4,5-D)pyrimidine compounds	Oct, 2024 (1 year, 2 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6525060	ASTRAZENECA	Triazolo(4,5-d)pyrimidine compounds	Dec, 2019 (6 years ago)
US6251910	ASTRAZENECA	1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists	Jul, 2018 (7 years ago)
US7250419	ASTRAZENECA	Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition	Dec, 2019 (6 years ago)
US7265124	ASTRAZENECA	Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound	Jul, 2021 (4 years ago)
US10300065	ASTRAZENECA	Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction	Jan, 2036 (10 years from now)
US8425934	ASTRAZENECA	Pharmaceutical compositions	Apr, 2030 (4 years from now)
US8425934 (Pediatric)	ASTRAZENECA	Pharmaceutical compositions	Oct, 2030 (4 years from now)
USRE46276 (Pediatric)	ASTRAZENECA	Triazolo(4,5-D)pyrimidine compounds	Apr, 2025 (8 months ago)
US10300065 (Pediatric)	ASTRAZENECA	Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction	Jul, 2036 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 20, 2016
New Indication(I-714)	Sep 03, 2018
New Strength(NS)	Sep 03, 2018
New Indication(I-851)	May 28, 2023
New Indication(I-848)	Nov 05, 2023
M(M-283)	May 09, 2025
Pediatric Exclusivity(PED)	Nov 09, 2025

Drugs and Companies using TICAGRELOR ingredient

NCE-1 date: 09 November, 2024

Market Authorisation Date: 03 September, 2015

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
90 mg	20 Jul, 2015	16	04 Sep, 2018	17 Apr, 2030	Eligible
60 mg	30 Sep, 2015	3	04 Sep, 2018	17 Apr, 2030	Eligible

Strength	Dosage	Availability
90MG	TABLET	Prescription
60MG	TABLET	Prescription

BRILINTA family patents

8. Bystolic patent expiration

Treatment: Treatment of hypertension

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6545040	December, 2015	Institution Denied	Forest Laboratories Holdings Limited	Lower Drug Prices For Consumers, LLC et al.
US6545040	December, 2015	Terminated-Denied	Forest Laboratories Holdings Limited	Lower Drug Prices For Consumers, LLC
US6545040	June, 1996	Decision	XHONNEUX et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6545040	ALLERGAN	Method of lowering the blood pressure	Dec, 2021 (4 years ago)
US5759580	ALLERGAN	Compositions containing micronized nebivolol	Jun, 2015 (10 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 17, 2012

Drugs and Companies using NEBIVOLOL HYDROCHLORIDE ingredient

NCE-1 date: 18 December, 2011

Market Authorisation Date: 17 December, 2007

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg, 5 mg, 10 mg, and 20 mg	19 Dec, 2011	7	16 Apr, 2015	17 Dec, 2021	Eligible

Strength	Dosage	Availability
EQ 2.5MG BASE	TABLET	Prescription
EQ 10MG BASE	TABLET	Prescription
EQ 20MG BASE	TABLET	Prescription
EQ 5MG BASE	TABLET	Prescription

BYSTOLIC family patents

9. Camzyos patent expiration

Treatment: Treatment of adults with symptomatic new york heart association (nyha) class ii-iii obstructive hypertrophic cardiomyopathy (hcm) to improve functional capacity and symptoms

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9181200	BRISTOL	Pyrimidinedione compounds	Jun, 2034 (8 years from now)
USRE50050	BRISTOL	Pyrimidinedione compounds	Apr, 2036 (10 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9585883	BRISTOL	Pyrimidinedione compounds	Jun, 2034 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-297)	Jun 15, 2026
New Chemical Entity Exclusivity(NCE)	Apr 28, 2027
Orphan Drug Exclusivity(ODE-398)	Apr 28, 2029

Drugs and Companies using MAVACAMTEN ingredient

NCE-1 date: 28 April, 2026

Market Authorisation Date: 28 April, 2022

Dosage: CAPSULE

Strength	Dosage	Availability
5MG	CAPSULE	Prescription
10MG	CAPSULE	Prescription
15MG	CAPSULE	Prescription
2.5MG	CAPSULE	Prescription

CAMZYOS family patents

10. Cialis patent expiration

Treatment: Erectile dysfunction; Treatment of erectile dysfunction; Treatment of sexual dysfunction

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6943166	June, 2018	Institution Denied	ICOS Corporation et al.	Aquestive Therapeutics, Inc.
US6943166	June, 2018	Terminated-Denied	ICOS Corporation	Aquestive Therapeutics, Inc.
US6943166	July, 2017	Terminated-Settled	ICOS Corporation	Dr. Reddy's Laboratories, Inc.
US6943166	July, 2017	Terminated-Settled	ICOS Corporation	Argentum Pharmaceuticals LLC
US6943166	November, 2016	Terminated-Settled	ICOS Corporation	Mylan Pharmaceuticals Inc.
US6943166	December, 2016	Institution Denied	ICOS Corporation et al.	MonoSol Rx, LLC
US6943166	December, 2016	Terminated-Denied	ICOS Corporation	MonoSol Rx, LLC
US6943166	February, 2016	Institution Denied	ICOS Corporation et al.	IntelGenx Corp.
US6943166	February, 2016	Terminated-Denied	ICOS Corporation	IntelGenx Corp.
US6821975	January, 2015	Final Written Decision	ICOS Corporation et al.	Actelion Pharmaceuticals Ltd
US6821975	January, 2015	FWD Entered	ICOS Corporation	Actelion Pharmaceuticals Ltd
US7182958	January, 2015	Final Written Decision	ICOS Corporation et al.	Actelion Pharmaceuticals Ltd
US7182958	January, 2015	FWD Entered	ICOS Corporation	Actelion Pharmaceuticals Ltd

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6943166 (Pediatric)	LILLY	Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction	Oct, 2020 (5 years ago)
US6821975	LILLY	Beta-carboline drug products	Nov, 2020 (5 years ago)
US6140329	LILLY	Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence	Jul, 2016 (9 years ago)
US7182958	LILLY	β-carboline pharmaceutical compositions	Apr, 2020 (5 years ago)
US5859006 (Pediatric)	LILLY	Tetracyclic derivatives; process of preparation and use	May, 2018 (7 years ago)
US6821975 (Pediatric)	LILLY	Beta-carboline drug products	May, 2021 (4 years ago)
US5859006	LILLY	Tetracyclic derivatives; process of preparation and use	Nov, 2017 (8 years ago)
US7182958 (Pediatric)	LILLY	β-carboline pharmaceutical compositions	Oct, 2020 (5 years ago)
US6943166	LILLY	Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction	Apr, 2020 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-641)	Oct 06, 2014
New Indication(I-642)	Oct 06, 2014
M(M-219)	Feb 15, 2021
Pediatric Exclusivity(PED)	Aug 15, 2021

Drugs and Companies using TADALAFIL ingredient

Market Authorisation Date: 07 January, 2008

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg	14 Oct, 2008	1	22 May, 2018	19 Nov, 2020	Eligible
5 mg, 10 mg and 20 mg	21 Nov, 2007	1	22 May, 2018	19 Nov, 2020	Eligible

Strength	Dosage	Availability
2.5MG	TABLET	Discontinued
20MG	TABLET	Prescription
10MG	TABLET	Prescription
5MG	TABLET	Prescription

CIALIS family patents

11. Cleviprex patent expiration

Treatment: Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable

Application	Filing Date	Opposition Party	Legal Status

EP11833207A	2015-12-23	Fresenius Kabi Deutschland GmbH	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5856346	CHIESI	Short-acting dihydropyridines	Jan, 2021 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5856346	CHIESI	Short-acting dihydropyridines	Jan, 2021 (5 years ago)
US5739152	CHIESI	Pharmaceutical emulsion	Apr, 2015 (10 years ago)
US8658676	CHIESI	Clevidipine emulsion formulations containing antimicrobial agents	Oct, 2031 (5 years from now)
US11103490	CHIESI	Clevidipine emulsion formulations containing antimicrobial agents	Oct, 2031 (5 years from now)
US10010537	CHIESI	Clevidipine emulsion formulations containing antimicrobial agents	Oct, 2031 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 01, 2013

Drugs and Companies using CLEVIDIPINE ingredient

NCE-1 date: 01 August, 2012

Market Authorisation Date: 01 August, 2008

Dosage: EMULSION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/50 mL and 50 mg/100 mL	02 Jul, 2019	1		10 Oct, 2031

Strength	Dosage	Availability
125MG/250ML (0.5MG/ML)	EMULSION	Discontinued
50MG/100ML (0.5MG/ML)	EMULSION	Prescription
25MG/50ML (0.5MG/ML)	EMULSION	Prescription

CLEVIPREX family patents

12. Corlanor patent expiration

Treatment: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7867996	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Dec, 2026 (11 months from now)
US7361649	AMGEN INC	β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)
US7879842	AMGEN INC	Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)
US7361650	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7879842 (Pediatric)	AMGEN INC	Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Aug, 2026 (7 months from now)
US7361649 (Pediatric)	AMGEN INC	β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Aug, 2026 (7 months from now)
US7361650 (Pediatric)	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Aug, 2026 (7 months from now)
US7867996 (Pediatric)	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Jun, 2027 (1 year, 5 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 15, 2020
Pediatric Exclusivity(PED)	Oct 22, 2026
New Product(NP)	Apr 22, 2022
Orphan Drug Exclusivity(ODE-234)	Apr 22, 2026

Drugs and Companies using IVABRADINE HYDROCHLORIDE ingredient

NCE-1 date: 16 October, 2019

Market Authorisation Date: 15 April, 2015

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 7.5 mg	15 Oct, 2019	6	30 Dec, 2021	22 Feb, 2026	Eligible

Strength	Dosage	Availability
EQ 5MG BASE	TABLET	Prescription
EQ 7.5MG BASE	TABLET	Prescription

CORLANOR family patents

13. Corlanor patent expiration

Treatment: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7867996	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Dec, 2026 (11 months from now)
US7361649	AMGEN INC	β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)
US7361650	AMGEN INC	γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)
US7879842	AMGEN INC	Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	Feb, 2026 (a month from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 15, 2020
Pediatric Exclusivity(PED)	Oct 22, 2026
New Product(NP)	Apr 22, 2022
Orphan Drug Exclusivity(ODE-234)	Apr 22, 2026

Drugs and Companies using IVABRADINE ingredient

NCE-1 date: 22 October, 2025

Market Authorisation Date: 22 April, 2019

Dosage: SOLUTION

CORLANOR family patents

14. Crestor patent expiration

Treatment: Use of rosuvastatin calcium to reduce elevated total-c, ldl-c, apob, nonhdl-c or tg levels; To increase hdl-c in adult patients with primary hyperlipidemia or mixed dyslipidemia; And to slow the progr...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6858618	ASTRAZENECA	Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia	Dec, 2021 (4 years ago)
US6316460 (Pediatric)	ASTRAZENECA	Pharmaceutical compositions	Feb, 2021 (4 years ago)
US7030152	ASTRAZENECA	Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease	Apr, 2018 (7 years ago)
US7964614	ASTRAZENECA	Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease	Apr, 2018 (7 years ago)
USRE37314 (Pediatric)	ASTRAZENECA	Pyrimidine derivatives	Jul, 2016 (9 years ago)
US6316460	ASTRAZENECA	Pharmaceutical compositions	Aug, 2020 (5 years ago)
US7030152 (Pediatric)	ASTRAZENECA	Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease	Oct, 2018 (7 years ago)
US7964614 (Pediatric)	ASTRAZENECA	Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease	Oct, 2018 (7 years ago)
US6858618 (Pediatric)	ASTRAZENECA	Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia	Jun, 2022 (3 years ago)
USRE37314	ASTRAZENECA	Pyrimidine derivatives	Jan, 2016 (10 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-573)	Nov 06, 2011
New Indication(I-611)	Oct 16, 2012
New Indication(I-621)	Feb 08, 2013
Pediatric Exclusivity(PED)	Apr 16, 2013
New Patient Population(NPP)	Nov 20, 2018
New Indication(I-732)	May 27, 2019
Orphan Drug Exclusivity(ODE)	May 27, 2023
Orphan Drug Exclusivity(ODE-118)	May 27, 2023

Drugs and Companies using ROSUVASTATIN CALCIUM ingredient

Market Authorisation Date: 12 August, 2003

Dosage: TABLET

CRESTOR family patents

15. Definity patent expiration

Treatment: Method of using the drug substance/drug product for ultrasound imaging

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8685441	LANTHEUS MEDCL	Preparation of a lipid blend and a phospholipid suspension containing the lipid blend	Jan, 2019 (6 years ago)
US5585112	LANTHEUS MEDCL	Method of preparing gas and gaseous precursor-filled microspheres	Dec, 2013 (12 years ago)
US6033645	LANTHEUS MEDCL	Methods for diagnostic imaging by regulating the administration rate of a contrast agent	Jun, 2016 (9 years ago)
US5527521	LANTHEUS MEDCL	Low density microspheres and suspensions and their use as contrast agents for computed tomography and in other applications	Feb, 2015 (10 years ago)
US9545457	LANTHEUS MEDCL	Preparation of a lipid blend and a phospholipid suspension containing the lipid blend	Jan, 2019 (6 years ago)
US8658205	LANTHEUS MEDCL	Preparation of a lipid blend and a phospholipid suspension containing the lipid blend	Jun, 2019 (6 years ago)
US11925695	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US10588988	LANTHEUS MEDCL	Methods and devices for preparation of ultrasound contrast agents	May, 2037 (11 years from now)
US9789210	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US10583207	LANTHEUS MEDCL	Lipid-encapsulated gas microsphere compositions and related methods	Dec, 2035 (9 years from now)
US10583208	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US11529431	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US11857646	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US11266750	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)
US12161730	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (11 years from now)

Drugs and Companies using PERFLUTREN ingredient

Market Authorisation Date: 31 July, 2001

Dosage: INJECTABLE

DEFINITY family patents

16. Edarbi patent expiration

Treatment: Treatment of hypertension

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7157584	AZURITY	Benzimidazole derivative and use thereof	May, 2025 (7 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5583141	AZURITY	Heterocyclic compounds and their use as angiotensin antagonists	Dec, 2013 (12 years ago)
US5958961	AZURITY	Pharmaceutical composition for angiotensin II-mediated diseases	Jun, 2014 (11 years ago)
US7572920	AZURITY	Benzimidazole derivative and use as a II receptor antagonist	Jan, 2025 (1 year, 2 days ago)
US9066936	AZURITY	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent	Mar, 2028 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 25, 2016

Drugs and Companies using AZILSARTAN KAMEDOXOMIL ingredient

NCE-1 date: 25 February, 2015

Market Authorisation Date: 25 February, 2011

Dosage: TABLET

EDARBI family patents

17. Effient patent expiration

Treatment: Treatment or prophylaxis of thrombosis or embolisms; Use of prasugrel and aspirin in patients requiring the reduction of thrombotic cardiovascular<...

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8404703	March, 2015	Final Written Decision	DAIICHI SANKYO COMPANY, LIMITED et al.	Accord Healthcare Inc., USA et al.
US8404703	March, 2015	FWD Entered	DAIICHI SANKYO COMPANY, LIMITED	Accord Healthcare Inc., USA
US8404703	October, 2015	Final Written Decision	Daiichi Sankyo Co., Ltd. et al.	Lupin, Ltd. et al.
US8404703	October, 2015	FWD Entered	Daiichi Sankyo Co., Ltd.	Lupin, Ltd.
US8569325	March, 2015	Final Written Decision	DAIICHI SANKYO COMPANY, LIMITED et al.	Accord Healthcare Inc., USA et al.
US8569325	March, 2015	FWD Entered	DAIICHI SANKYO COMPANY, LIMITED	Accord Healthcare Inc., USA
US8569325	October, 2015	Final Written Decision	Daiichi Sankyo Co., Ltd. et al.	Lupin, Ltd. et al.
US8569325	October, 2015	FWD Entered	Daiichi Sankyo Co., Ltd.	Lupin, Ltd.
US8404703	June, 2015	Institution Denied	DAIICHI SANKYO COMPANY, LIMITED et al.	Panacea Biotec Ltd.
US8404703	June, 2015	Terminated-Denied	DAIICHI SANKYO COMPANY, LIMITED	Panacea Biotec Ltd.
US8569325	June, 2015	Institution Denied	DAIICHI SANKYO COMPANY, LIMITED et al.	Panacea Biotec Ltd.
US8569325	June, 2015	Terminated-Denied	DAIICHI SANKYO COMPANY, LIMITED	Panacea Biotec Ltd.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6693115	COSETTE	Acid addition salts of hydropyridine derivatives	Jul, 2021 (4 years ago)
US8404703	COSETTE	Medicinal compositions containing aspirin	Mar, 2022 (3 years ago)
US8569325	COSETTE	Method of treatment with coadministration of aspirin and prasugrel	Jan, 2023 (3 years ago)
US5288726	COSETTE	Tetrahydrothienopyridine derivatives, furo and pyrrolo analogs thereof and their preparation and uses for inhibiting blood platelet aggregation	Apr, 2017 (8 years ago)
US5288726 (Pediatric)	COSETTE	Tetrahydrothienopyridine derivatives, furo and pyrrolo analogs thereof and their preparation and uses for inhibiting blood platelet aggregation	Oct, 2017 (8 years ago)
US8569325 (Pediatric)	COSETTE	Method of treatment with coadministration of aspirin and prasugrel	Jul, 2023 (2 years ago)
US8404703 (Pediatric)	COSETTE	Medicinal compositions containing aspirin	Jul, 2023 (2 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 10, 2014
M(M-182)	Jul 12, 2019
Pediatric Exclusivity(PED)	Jan 12, 2020

Drugs and Companies using PRASUGREL HYDROCHLORIDE ingredient

NCE-1 date: 12 January, 2019

Market Authorisation Date: 10 July, 2009

Dosage: TABLET

EFFIENT family patents

18. Eliquis patent expiration

Treatment: Reducing the risk of stroke and systemic embolism; Prophylaxis of pulmonary embolism

Application	Filing Date	Opposition Party	Legal Status

EP17175864A	2020-08-13	STADA Arzneimittel AG	Granted and Under Opposition
EP17175864A	2020-08-12	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP17175864A	2020-08-10	Generics (U.K.) Limited	Granted and Under Opposition
EP17175864A	2020-08-07	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP17175864A	2020-08-07	Wittkopp, Alexander	Granted and Under Opposition
EP17175864A	2020-08-06	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP17175864A	2020-08-06	von Seebach, Malte	Granted and Under Opposition
EP17175864A	2020-08-06	Kutzenberger Wolff & Partner	Granted and Under Opposition
EP17175864A	2020-08-04	Teva Pharmaceutical Industries LTD.	Granted and Under Opposition
EP17175864A	2020-08-04	Zentiva k.s.	Granted and Under Opposition
EP17175864A	2020-08-03	Krka, d.d., Novo mesto	Granted and Under Opposition
EP17175864A	2020-08-03	SANDOZ AG	Granted and Under Opposition
EP17178613A	2020-07-16	STADA Arzneimittel AG	Granted and Under Opposition
EP17175788A	2020-07-16	Generics (U.K.) Limited	Granted and Under Opposition
EP17175788A	2020-07-16	STADA Arzneimittel AG	Granted and Under Opposition
EP17178613A	2020-07-16	Generics (U.K.) Limited	Granted and Under Opposition
EP17178613A	2020-07-15	Sandoz AG	Granted and Under Opposition
EP17178613A	2020-07-15	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP17178613A	2020-07-15	KRKA, d.d., Novo mesto	Granted and Under Opposition
EP17175788A	2020-07-15	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP17175788A	2020-07-15	KRKA, d.d., Novo mesto	Granted and Under Opposition
EP17175788A	2020-07-15	Sandoz AG	Granted and Under Opposition
EP17178613A	2020-07-14	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP17175788A	2020-07-14	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP17175788A	2020-07-14	Medichem S.A.	Granted and Under Opposition
EP17178613A	2020-07-14	Medichem S.A.	Granted and Under Opposition
EP17175788A	2020-07-13	Kutzenberger Wolff & Partner	Granted and Under Opposition
EP17178613A	2020-07-13	Zentiva k.s.	Granted and Under Opposition
EP17178613A	2020-07-13	Kutzenberger Wolff & Partner	Granted and Under Opposition
EP17175788A	2020-07-10	Zentiva k.s.	Granted and Under Opposition
EP17178613A	2020-07-02	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP17175788A	2020-07-02	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP15190823A	2019-09-05	STADA Arzneimittel AG	Granted and Under Opposition
EP15190823A	2019-09-04	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP15190823A	2019-09-04	Generics (U.K.) Limited	Granted and Under Opposition
EP15190823A	2019-09-04	Zentiva, k.s.	Granted and Under Opposition
EP15190823A	2019-09-03	KRKA, d.d., Novo mesto	Granted and Under Opposition
EP15190823A	2019-09-03	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP15190823A	2019-08-30	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition
EP15190823A	2019-08-29	Sandoz AG	Granted and Under Opposition
EP15190823A	2019-08-27	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP11707284A	2016-09-16	STADA Arzneimittel AG	Revoked
EP11707284A	2016-09-16	Galenicum Health S.L.	Revoked
EP11707284A	2016-09-16	Generics (U.K.) Limited	Revoked
EP11707284A	2016-09-16	Hamm&Wittkopp Patentanwälte PartmbB	Revoked
EP11707284A	2016-09-16	Intas Pharmaceuticals Ltd.	Revoked
EP11707284A	2016-09-16	LEK Pharmaceuticals d.d.	Revoked
EP11707284A	2016-09-16	Zentiva k.s.	Revoked
EP11707284A	2016-09-16	KRKA, d.d., Novo mesto	Revoked
EP11707284A	2016-09-15	Plougmann Vingtoft a/s	Revoked
EP11707284A	2016-09-15	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Revoked
EP11707284A	2016-09-14	Teva Pharmaceutical Industries Ltd	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6967208	BRISTOL MYERS SQUIBB	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors	Nov, 2026 (10 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6413980	BRISTOL MYERS SQUIBB	Nitrogen containing heterobicycles as factor Xa inhibitors	Dec, 2019 (6 years ago)
US9326945	BRISTOL MYERS SQUIBB	Apixaban formulations	Feb, 2031 (5 years from now)
US6967208 (Pediatric)	BRISTOL MYERS SQUIBB	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors	May, 2027 (1 year, 4 months from now)
US9326945 (Pediatric)	BRISTOL MYERS SQUIBB	Apixaban formulations	Aug, 2031 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-681)	Mar 03, 2017
New Indication(I-661)	Aug 21, 2017
New Indication(I-690)	Aug 21, 2017
New Indication(I-691)	Aug 21, 2017
New Chemical Entity Exclusivity(NCE)	Dec 28, 2017
New Patient Population(NPP)	Apr 17, 2028
New Strength(NS)	Apr 17, 2028
Pediatric Exclusivity(PED)	Oct 17, 2028

Drugs and Companies using APIXABAN ingredient

NCE-1 date: 18 October, 2027

Market Authorisation Date: 17 April, 2025

Dosage: TABLET; TABLET, FOR SUSPENSION

ELIQUIS family patents

19. Inpefa patent expiration

Treatment: Reduction of risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure in adults with heart failure or type ...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8476413	LEXICON PHARMS INC	Sulfanyl-tetrahydropyran-based compounds and methods of their use	May, 2028 (2 years from now)
US7781577	LEXICON PHARMS INC	Inhibitors of sodium glucose co-transporter 2 and methods of their use	May, 2028 (2 years from now)
US8217156	LEXICON PHARMS INC	Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use	Oct, 2030 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 26, 2028

Drugs and Companies using SOTAGLIFLOZIN ingredient

NCE-1 date: 27 May, 2027

Market Authorisation Date: 26 May, 2023

Dosage: TABLET

INPEFA family patents

20. Inspra patent expiration

Treatment: Treatment of conditions for which an aldosterone receptor blocker is indicated, such as hypertension, heart failure, and post-myocardial infarction; Use of eplerenone in combination with an angiotensi...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6863902	UPJOHN	Immediate release eplerenone compositions	Apr, 2020 (5 years ago)
US6558707 (Pediatric)	UPJOHN	Immediate release eplerenone compositions	Jun, 2020 (5 years ago)
US6747020 (Pediatric)	UPJOHN	Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor	May, 2020 (5 years ago)
US7157101 (Pediatric)	UPJOHN	Micronized eplerenone compositions	Jun, 2020 (5 years ago)
US6495165 (Pediatric)	UPJOHN	Eplerenone compositions having improved bioavailability	Jun, 2020 (5 years ago)
US6410524 (Pediatric)	UPJOHN	Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease	May, 2020 (5 years ago)
US6410054 (Pediatric)	UPJOHN	Immediate release eplerenone compositions	Jun, 2020 (5 years ago)
US6534093 (Pediatric)	UPJOHN	Immediate release eplerenone compositions	Jun, 2020 (5 years ago)
US6863902 (Pediatric)	UPJOHN	Immediate release eplerenone compositions	Oct, 2020 (5 years ago)
US6410524	UPJOHN	Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease	Nov, 2019 (6 years ago)
US6410054	UPJOHN	Immediate release eplerenone compositions	Dec, 2019 (6 years ago)
US6747020	UPJOHN	Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor	Nov, 2019 (6 years ago)
US6534093	UPJOHN	Immediate release eplerenone compositions	Dec, 2019 (6 years ago)
US7157101	UPJOHN	Micronized eplerenone compositions	Dec, 2019 (6 years ago)
US6495165	UPJOHN	Eplerenone compositions having improved bioavailability	Dec, 2019 (6 years ago)
US6558707	UPJOHN	Immediate release eplerenone compositions	Dec, 2019 (6 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Jul 31, 2011

Drugs and Companies using EPLERENONE ingredient

Market Authorisation Date: 27 September, 2002

Dosage: TABLET

INSPRA family patents

21. Jardiance patent expiration

Treatment: Method of treating type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin; Method of treating type 2 diabetes mellitus in a patient with renal impairment...

Application	Filing Date	Opposition Party	Legal Status

EP14715274A	2023-04-20	TEVA PHARMACEUTICAL INDUSTRIES, LTD.	Granted and Under Opposition
EP10703288A	2021-01-11	Generics (U.K.) Limited	Granted and Under Opposition
EP10703288A	2021-01-08	STADA Arzneimittel AG	Granted and Under Opposition
EP10703288A	2020-12-22	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP14715578A	2019-08-14	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP14715578A	2019-08-14	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP14715578A	2019-08-14	Generics (U.K.) Limited	Granted and Under Opposition
EP14715578A	2019-08-14	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP14715578A	2019-08-14	Gillard, Richard Edward	Granted and Under Opposition
EP14715578A	2019-08-12	EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság	Granted and Under Opposition
EP14715578A	2019-08-09	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP14715578A	2019-08-02	KRKA, d.d., Novo mesto	Granted and Under Opposition
EP08787264A	2017-07-12	STADA Arzneimittel AG	Granted and Under Opposition
EP08787264A	2017-07-12	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP08787264A	2017-07-12	Hexal AG	Granted and Under Opposition
EP08787264A	2017-07-11	Generics (U.K.) Limited	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7579449	BOEHRINGER INGELHEIM	Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture	Aug, 2028 (2 years from now)
US7713938	BOEHRINGER INGELHEIM	Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments	Apr, 2027 (1 year, 3 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10406172	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Jun, 2030 (4 years from now)
US9949998	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Jun, 2034 (8 years from now)
US9949997	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	May, 2034 (8 years from now)
US10258637	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US12115179	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Feb, 2030 (4 years from now)
US8551957	BOEHRINGER INGELHEIM	Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate	Oct, 2029 (3 years from now)
US12433906	BOEHRINGER INGELHEIM	NA	Apr, 2034 (8 years from now)
US12263153	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US12427162	BOEHRINGER INGELHEIM	NA	Apr, 2034 (8 years from now)
US11090323	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US11666590	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US11833166	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US11813275	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (8 years from now)
US7579449 (Pediatric)	BOEHRINGER INGELHEIM	Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture	Feb, 2029 (3 years from now)
US7713938 (Pediatric)	BOEHRINGER INGELHEIM	Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments	Oct, 2027 (1 year, 9 months from now)
US9949998 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Dec, 2034 (8 years from now)
US9949997 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Nov, 2034 (8 years from now)
US8551957 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate	Apr, 2030 (4 years from now)
US10258637 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Oct, 2034 (8 years from now)
US11813275 (Pediatric)	BOEHRINGER INGELHEIM	NA	Oct, 2034 (8 years from now)
US11833166 (Pediatric)	BOEHRINGER INGELHEIM	NA	Oct, 2034 (8 years from now)
US12115179 (Pediatric)	BOEHRINGER INGELHEIM	NA	Aug, 2030 (4 years from now)
US11090323 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Oct, 2034 (8 years from now)
US12433906 (Pediatric)	BOEHRINGER INGELHEIM	NA	Oct, 2034 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-159)	Jun 26, 2018
M(M-160)	Jun 26, 2018
M(M-161)	Jun 26, 2018
M(M-174)	Mar 18, 2019
New Chemical Entity Exclusivity(NCE)	Aug 01, 2019
New Indication(I-739)	Dec 02, 2019
New Indication(I-869)	Aug 18, 2024
M(M-82)	Feb 24, 2025
Pediatric Exclusivity(PED)	Dec 20, 2026
New Patient Population(NPP)	Jun 20, 2026
New Indication(I-922)	Sep 21, 2026

Drugs and Companies using EMPAGLIFLOZIN ingredient

NCE-1 date: 20 December, 2025

Market Authorisation Date: 01 August, 2014

Dosage: TABLET

JARDIANCE family patents

22. Juxtapid patent expiration

Treatment: Treatment of hypercholesterolemia, hyperlipidemia and hyperlipoproteinemia in patients with homozygous familial hypercholesterolemia; Treatment of hypercholesterolemia by decreasing the amount or acti...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5712279	CHIESI	Inhibitors of microsomal triglyceride transfer protein and method	Feb, 2020 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5739135	CHIESI	Inhibitors of microsomal triglyceride transfer protein and method	Apr, 2015 (10 years ago)
US6492365	CHIESI	Microsomal triglyceride transfer protein	Dec, 2019 (6 years ago)
US5712279	CHIESI	Inhibitors of microsomal triglyceride transfer protein and method	Feb, 2015 (10 years ago)
US7932268	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects	Aug, 2027 (1 year, 7 months from now)
US8618135	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects	Mar, 2025 (10 months ago)
US10016404	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects	Mar, 2025 (10 months ago)
US9433617	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects	Mar, 2025 (10 months ago)
US9265758	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects	Mar, 2025 (10 months ago)
US9364470	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects	Mar, 2025 (10 months ago)
US9861622	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects	Mar, 2025 (10 months ago)
US10555938	CHIESI	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects	Mar, 2025 (10 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 21, 2017
Orphan Drug Exclusivity(ODE)	Dec 21, 2019
Orphan Drug Exclusivity(ODE-36)	Dec 21, 2019

Drugs and Companies using LOMITAPIDE MESYLATE ingredient

NCE-1 date: 21 December, 2016

Market Authorisation Date: 21 December, 2012

Dosage: CAPSULE

JUXTAPID family patents

23. Kengreal patent expiration

Treatment: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a ...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6114313	CHIESI	Pharmaceutical compositions for freeze drying	Dec, 2018 (7 years ago)
US6130208	CHIESI	Formulation containing a nucleotide analogue	Jun, 2023 (2 years ago)
US8759316	CHIESI	Maintenance of platelet inhibition during antiplatelet therapy	May, 2029 (3 years from now)
US10039780	CHIESI	Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same	Jul, 2035 (9 years from now)
US9427448	CHIESI	Methods of treating, reducing the incidence of, and/or preventing ischemic events	Nov, 2030 (4 years from now)
US9925265	CHIESI	Methods of treating or preventing stent thrombosis	May, 2029 (3 years from now)
US8680052	CHIESI	Methods of treating, reducing the incidence of, and/or preventing ischemic events	Mar, 2033 (7 years from now)
US9439921	CHIESI	Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same	Jul, 2035 (9 years from now)
US9700575	CHIESI	Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same	Jul, 2035 (9 years from now)
US9295687	CHIESI	Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same	Jul, 2035 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 22, 2020

Drugs and Companies using CANGRELOR ingredient

NCE-1 date: 23 June, 2019

Market Authorisation Date: 22 June, 2015

Dosage: POWDER

KENGREAL family patents

24. Kynamro patent expiration

Treatment: Adjunctive therapy to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein b, total cholesterol, and non-high density lipoprotein cholesterol in pts with h...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7511131	KASTLE THERAPS LLC	Antisense modulation of apolipoprotein B expression	Jan, 2027 (1 year, 19 days from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5914396	KASTLE THERAPS LLC	2'-O-modified nucleosides and phosphoramidites	Jun, 2016 (9 years ago)
US6222025	KASTLE THERAPS LLC	Process for the synthesis of 2′-O-substituted pyrimidines and oligomeric compounds therefrom	Mar, 2015 (10 years ago)
US6166197	KASTLE THERAPS LLC	Oligomeric compounds having pyrimidine nucleotide (S) with 2'and 5 substitutions	Dec, 2017 (8 years ago)
US7101993	KASTLE THERAPS LLC	Oligonucleotides containing 2′-O-modified purines	Sep, 2023 (2 years ago)
US7407943	KASTLE THERAPS LLC	Antisense modulation of apolipoprotein B expression	Aug, 2021 (4 years ago)
US7015315	KASTLE THERAPS LLC	Gapped oligonucleotides	Mar, 2023 (2 years ago)
US6451991	KASTLE THERAPS LLC	Sugar-modified gapped oligonucleotides	Feb, 2017 (8 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 29, 2018
Orphan Drug Exclusivity(ODE)	Jan 29, 2020
Orphan Drug Exclusivity(ODE-41)	Jan 29, 2020

Drugs and Companies using MIPOMERSEN SODIUM ingredient

NCE-1 date: 29 January, 2017

Market Authorisation Date: 29 January, 2013

Dosage: SOLUTION

KYNAMRO family patents

25. Leqvio patent expiration

Treatment: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic

Application	Filing Date	Opposition Party	Legal Status

EP06025389A	2017-12-15	Silence Therapeutics GmbH	Revoked
EP10011217A	2017-04-13	Silence Therapeutics GmbH	Opposition rejected
EP10008929A	2015-10-06	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008931A	2013-07-26	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP03716126A	2013-07-16	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP10008930A	2013-05-22	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008930A	2013-05-21	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-06-01	Alcon Research, Ltd.	Patent maintained as amended
EP03743684A	2011-05-31	Dharmacon, Inc.	Patent maintained as amended
EP03743684A	2011-05-31	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-05-26	Novartis AG	Patent maintained as amended
EP03743684A	2011-05-18	Sanofi-Aventis Deutschland GmbH	Patent maintained as amended
EP02702247A	2010-12-10	Silence Therapeutics AG	Revoked
EP02702247A	2010-12-10	Sirna Therapeutics	Revoked
EP05002454A	2009-09-24	ROQUES, Sarah Elizabeth	Granted and Under Opposition
EP05002454A	2009-09-24	Silence Therapeutics AG	Granted and Under Opposition
EP05002454A	2009-09-23	PFIZER LIMITED	Granted and Under Opposition
EP05002454A	2009-09-23	Sanofi-Aventis Deutschland GmbH	Granted and Under Opposition
EP05002454A	2009-09-21	Sirna Therapeutics	Granted and Under Opposition
EP02710786A	2007-02-28	Sirna Therapeutics	Opposition rejected
EP02003683A	2006-03-08	Abbott Laboratories	Patent maintained as amended
EP02003683A	2006-03-08	atugen AG	Patent maintained as amended
EP02003683A	2006-03-07	Quark Biotech, Inc.	Patent maintained as amended
EP02003683A	2006-03-07	Sirna Therapeutics, Inc.	Patent maintained as amended
EP00910510A	2003-05-28	Isis Pharmaceuticals, Inc.	Revoked
EP00910510A	2003-05-28	atugen AG	Revoked
EP00910510A	2003-05-28	Aventis Pharma Deutschland GmbH	Revoked
EP00910510A	2003-05-28	Grund, Martin, Dr.	Revoked
EP00910510A	2003-05-28	JANSSEN PHARMACEUTICA N.V.	Revoked
EP00910510A	2003-05-28	AstraZeneca AB	Revoked
EP00910510A	2003-05-28	Novartis AG	Revoked
EP00910510A	2003-05-20	Sirna Therapeutics, Inc.	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11078485	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (2 years ago)
US9708610	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (2 years ago)
US9074213	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Mar, 2022 (3 years ago)
US8232383	NOVARTIS	RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)	Feb, 2023 (2 years ago)
US8546143	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Apr, 2022 (3 years ago)
US10125369	NOVARTIS	PCSK9 iRNA compositions and methods of use thereof	Aug, 2034 (8 years from now)
US9370582	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (2 years from now)
US8106022	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (3 years from now)
US11530408	NOVARTIS	Therapeutic compositions	May, 2024 (1 year, 7 months ago)
US9708615	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 10 months ago)
US10273477	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 10 months ago)
US8828956	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (2 years from now)
US8809292	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	May, 2027 (1 year, 3 months from now)
US10131907	NOVARTIS	Glycoconjugates of RNA interference agents	Aug, 2028 (2 years from now)
US10806791	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (2 years from now)
US10669544	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 10 months ago)
US12460206	NOVARTIS	NA	Aug, 2034 (8 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10590418	NOVARTIS	Methods and compositions for RNAi mediated inhibition of gene expression in mammals	Jul, 2022 (3 years ago)
US10266825	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (2 years ago)
US10851377	NOVARTIS	Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder	Aug, 2036 (10 years from now)
US8222222	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	Dec, 2027 (1 year, 11 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: 22 December, 2025

Market Authorisation Date: 22 December, 2021

Dosage: SOLUTION

LEQVIO family patents

26. Letairis patent expiration

Treatment: Method to treat pulmonary hypertension by administering ambrisentan to a patient; Treatment of pulmonary arterial hypertension by inhibiting endothelin receptors; For the treatment of pulmonary hypert...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5703017	GILEAD	3-(Het) arylcarboxylic acid derivatives, their preparation and intermediates for their preparation	Dec, 2014 (11 years ago)
US7601730	GILEAD	Carboxylic acid derivatives, their preparation and use	Oct, 2015 (10 years ago)
USRE42462	GILEAD	Carboxylic acid derivatives, their preparation and use	Jul, 2018 (7 years ago)
US7109205	GILEAD	Carboxylic acid derivatives, their preparation and use	Oct, 2015 (10 years ago)
US5840722	GILEAD	Use of carboxylic acid derivatives as drugs	Nov, 2015 (10 years ago)
US8349843	GILEAD	Carboxylic acid derivatives, their preparation and use	Oct, 2015 (10 years ago)
US9474752	GILEAD	Method for treating a pulmonary hypertension condition	Dec, 2027 (1 year, 10 months from now)
US9549926	GILEAD	Compositions and methods of treating pulmonary hypertension	Oct, 2031 (5 years from now)
US8377933	GILEAD	Method for treating a pulmonary hypertension condition	Dec, 2027 (1 year, 10 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 15, 2012
Orphan Drug Exclusivity(ODE)	Jun 15, 2014
New Indication(I-716)	Oct 02, 2018

Drugs and Companies using AMBRISENTAN ingredient

NCE-1 date: 16 June, 2011

Market Authorisation Date: 15 June, 2007

Dosage: TABLET

LETAIRIS family patents

27. Lexiscan patent expiration

Treatment: Method of myocardial imaging; Method for stimulating coronary vasodilation for purposes of imaging the heart; A method of myocardial perfusion imaging and increasing coronary blood flow; Method of pro...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE47351	ASTELLAS	2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists	Jun, 2019 (6 years ago)
US8106183	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (1 year, 23 days from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8536150	ASTELLAS	Methods of myocardial perfusion imaging	Jun, 2019 (6 years ago)
US8470801	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (6 years ago)
US8106029	ASTELLAS	Use of A2A adenosine receptor agonists	Jun, 2019 (6 years ago)
US7655637	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (6 years ago)
US7683037	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (6 years ago)
US7655636	ASTELLAS	Use of A2A adenosine receptor agonists	Jun, 2019 (6 years ago)
US7582617	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (6 years ago)
US9289446	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (6 years ago)
US7144872	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (6 years ago)
US6642210	ASTELLAS	2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists	Jun, 2019 (6 years ago)
US9085601	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (1 year, 23 days from now)
US9045519	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (6 years ago)
US8183226	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (6 years ago)
US7183264	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (6 years ago)
US6403567	ASTELLAS	N-pyrazole A2A adenosine receptor agonists	Apr, 2022 (3 years ago)
US8133879	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (6 years ago)
USRE47301	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (1 year, 23 days from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 10, 2013
M(M-194)	Jan 17, 2020

Drugs and Companies using REGADENOSON ingredient

NCE-1 date: 10 April, 2012

Market Authorisation Date: 10 April, 2008

Dosage: SOLUTION

LEXISCAN family patents

28. Livalo patent expiration

Treatment: Adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein b, triglycerides and to increase hdl-c in adult patients with primary hyperlipidemi...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5753675	KOWA CO	Quinoline analogs of mevalonolactone and derivatives thereof	May, 2015 (10 years ago)
US6465477	KOWA CO	Stable pharmaceutical composition	Dec, 2016 (9 years ago)
US5856336 (Pediatric)	KOWA CO	Quinoline type mevalonolactones	Jun, 2021 (4 years ago)
US5856336	KOWA CO	Quinoline type mevalonolactones	Jan, 2021 (5 years ago)
US5854259	KOWA CO	Quinoline type mevalonolactones	Dec, 2015 (10 years ago)
US7022713	KOWA CO	Hyperlipemia therapeutic agent	Feb, 2024 (1 year, 10 months ago)
US8557993	KOWA CO	Crystalline forms of pitavastatin calcium	Feb, 2024 (1 year, 11 months ago)
US7022713 (Pediatric)	KOWA CO	Hyperlipemia therapeutic agent	Aug, 2024 (1 year, 4 months ago)
US8557993 (Pediatric)	KOWA CO	Crystalline forms of pitavastatin calcium	Aug, 2024 (1 year, 5 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 03, 2014
New Patient Population(NPP)	May 16, 2022
Pediatric Exclusivity(PED)	Nov 16, 2022

Drugs and Companies using PITAVASTATIN CALCIUM ingredient

NCE-1 date: 16 November, 2021

Market Authorisation Date: 03 August, 2009

Dosage: TABLET

LIVALO family patents

29. Multaq patent expiration

Treatment: Reduction of the risk of hospitalization for atrial fibrillation; Management of risk of dronedarone/beta-blocker interaction in patients in sinus rhythm with a history of paroxysmal or persistent af; ...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7323493	SANOFI AVENTIS US	Solid pharmaceutical composition containing benzofuran derivatives	Jun, 2018 (7 years ago)
US5223510	SANOFI AVENTIS US	Alkylaminoalkyl derivatives of benzofuran, benzothiophene, indole and indolizine, process for their preparation and compositions containing them	Jul, 2016 (9 years ago)
US8318800	SANOFI AVENTIS US	Solid pharmaceutical compositions containing benzofuran derivatives	Jun, 2018 (7 years ago)
US8602215	SANOFI AVENTIS US	Methods for reducing the risk of an adverse dronedarone/beta-blockers interaction in a patient suffering from atrial fibrillation	Jun, 2031 (5 years from now)
US8410167	SANOFI AVENTIS US	Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality	Apr, 2029 (3 years from now)
US9107900	SANOFI AVENTIS US	Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of morality	Apr, 2029 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 01, 2014

Drugs and Companies using DRONEDARONE HYDROCHLORIDE ingredient

NCE-1 date: 01 July, 2013

Market Authorisation Date: 01 July, 2009

Dosage: TABLET

MULTAQ family patents

30. Natrecor patent expiration

Treatment: Method to induce natriuresis, diuresis and/or vasodilation

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5114923	SCIOS LLC	Recombinant techniques for production of novel natriuretic and vasodilator peptides	May, 2014 (11 years ago)

Drugs and Companies using NESIRITIDE ingredient

Market Authorisation Date: 10 August, 2001

Dosage: FOR SOLUTION

NATRECOR family patents

31. Nexletol patent expiration

Treatment: Use of nexletol as an adjunct to diet and maximally tolerated statin therapy to lower ldl-c in adults with heterozygous familial hypercholesterolemia or established atherosclerotic Read More

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US12404227	ESPERION THERAPS INC	NA	Jun, 2040 (14 years from now)
US7335799	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2030 (4 years from now)
US11613511	ESPERION THERAPS INC	Methods of making bempedoic acid and compositions of the same	Jun, 2040 (14 years from now)
US12398087	ESPERION THERAPS INC	NA	Jun, 2040 (14 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10118881	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2023 (2 years ago)
US8497301	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2023 (2 years ago)
US10941095	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2023 (2 years ago)
US9000041	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2023 (2 years ago)
US9624152	ESPERION THERAPS INC	Hydroxyl compounds and compositions for cholesterol management and related uses	Dec, 2023 (2 years ago)
US11744816	ESPERION THERAPS INC	Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease	Mar, 2036 (10 years from now)
US11926584	ESPERION THERAPS INC	Methods of making bempedoic acid and compositions of the same	Jun, 2040 (14 years from now)
US11760714	ESPERION THERAPS INC	Methods of making bempedoic acid and compositions of the same	Jun, 2040 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 21, 2025
New Indication(I-943)	Mar 22, 2027
New Indication(I-944)	Mar 22, 2027

Drugs and Companies using BEMPEDOIC ACID ingredient

NCE-1 date: 22 February, 2024

Market Authorisation Date: 21 February, 2020

Dosage: TABLET

NEXLETOL family patents

32. Opsumit patent expiration

Treatment: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties; Method of treating pulmonary arterial hyp...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7094781	ACTELION	Sulfamides and their use as endothelin receptor antagonists	Dec, 2025 (a month ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8268847	ACTELION	Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor	Apr, 2029 (3 years from now)
US9265762	ACTELION	Stable pharmaceutical compositions comprising a pyrimidine-sulfamide	May, 2027 (1 year, 4 months from now)
US10946015	ACTELION	Stable pharmaceutical compositions comprising a pyrimidine-sulfamide	Sep, 2026 (8 months from now)
US8367685	ACTELION	Stable pharmaceutical compositions comprising a pyrimidine-sulfamide	Oct, 2028 (2 years from now)
US8268847 (Pediatric)	ACTELION	NA	Oct, 2029 (3 years from now)
US7094781 (Pediatric)	ACTELION	NA	Jun, 2026 (4 months from now)
US8367685 (Pediatric)	ACTELION	NA	Apr, 2029 (3 years from now)
US9265762 (Pediatric)	ACTELION	NA	Nov, 2027 (1 year, 10 months from now)
US10946015 (Pediatric)	ACTELION	NA	Mar, 2027 (1 year, 1 month from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 18, 2018
Orphan Drug Exclusivity(ODE)	Oct 18, 2020
Orphan Drug Exclusivity(ODE-54)	Oct 18, 2020
M(M-187)	Feb 28, 2028
Pediatric Exclusivity(PED)	Aug 28, 2028

Drugs and Companies using MACITENTAN ingredient

NCE-1 date: 29 August, 2027

Market Authorisation Date: 18 October, 2013

Dosage: TABLET

OPSUMIT family patents

33. Ozempic patent expiration

What is Ozempic?

Ozempic (semaglutide) is an injectable medication used to improve blood sugar levels in adults with type 2 diabetes. It belongs to a class of drugs called GLP-1 receptor agonists and works by mimicking the effects of the hormone GLP-1, which helps regulate blood sugar levels. Ozempic slows digestion and decreases appetite, leading to improved glycemic control and potential weight loss benefits.

What is the Ozempic controversy?

The injectable diabetes medication Ozempic (semaglutide) has recently seen its FDA-approved label updated to warn of potential serious intestinal side effects like obstruction or blockage. The newly added FDA warning highlights that Ozempic may cause severe gastrointestinal issues like intestinal obstruction, intense abdominal pain, vomiting, constipation, and abdominal swelling.

Treatment: Method of treating type 2 diabetes mellitus; A method of treating type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof; Ozempic is indica...

Application	Filing Date	Opposition Party	Legal Status

EP02726984A		Genentech, Inc.	Patent maintained as amended
EP13737808A	2021-01-08	Galenicum Health S.L.U.	Granted and Under Opposition
EP13737808A	2021-01-07	Teva Pharmaceutical Industries LTD.	Granted and Under Opposition
EP13737808A	2021-01-07	Generics [UK] Limited	Granted and Under Opposition
EP17196501A	2019-12-06	Hoffmann Eitle	Granted and Under Opposition
EP17196501A	2019-12-06	Generics (U.K.) Limited	Granted and Under Opposition
EP17196501A	2019-12-05	Dr. Reddy's Laboratories Limited	Granted and Under Opposition
EP17196501A	2019-12-04	Galenicum Health S.L.U.	Granted and Under Opposition
EP17196501A	2019-12-04	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP04797453A	2018-08-22	Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB	Opposition rejected
EP04797453A	2018-08-21	Wittkopp, Alexander	Opposition rejected
EP04797453A	2018-08-21	Generics (U.K.) Limited	Opposition rejected
EP04797453A	2018-08-21	Teva Pharmaceutical Industries Ltd	Opposition rejected
EP04797453A	2018-08-20	Fresenius Kabi Deutschland GmbH	Opposition rejected
EP04797453A	2018-08-20	Sandoz AG	Opposition rejected
EP06701034A	2018-01-19	Schwöbel, Thilo	Opposition rejected
EP06754730A	2011-12-02	Ypsomed AG	Patent maintained as amended
EP06754730A	2011-11-30	WMC Matthes Consulting	Patent maintained as amended
EP06725149A	2011-05-04	AMYLIN PHARMACEUTICALS, INC.	Opposition rejected
EP06762643A	2010-07-30	Sanofi-Aventis Deutschland GmbH	Patent maintained as amended
EP05796880A	2010-07-14	Ypsomed AG	Granted and Under Opposition
EP05796880A	2010-07-14	Stöckeler, Ferdinand	Granted and Under Opposition
EP05796880A	2010-07-13	OWEN MUMFORD LIMITED	Granted and Under Opposition
EP05796880A	2010-07-13	Ferring International Center S.A.	Granted and Under Opposition
EP05796880A	2010-07-12	COPERNICUS sp. zo.o.	Granted and Under Opposition
EP05796880A	2010-07-12	Genentech, Inc.	Granted and Under Opposition
EP06121820A	2010-05-18	SANOFI-AVENTIS DEUTSCHLAND GMBH	Opposition rejected
EP02726984A	2006-03-01	TecPharma Licensing AG	Patent maintained as amended
EP02726984A	2006-02-23	OWEN MUMFORD LIMITED	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10335462	March, 2024	Pending	Novo Nordisk A/S	Apotex Inc. et al.
US10335462	March, 2023	Terminated-Settled	Novo Nordisk A/S	Mylan Pharmaceuticals Inc. et al.
US10335462	October, 2023	Terminated-Settled	Novo Nordisk A/S	DR. REDDY'S LABORATORIES, INC. et al.
US10335462	November, 2023	Terminated-Settled	Novo Nordisk A/S	Sun Pharmaceutical Industries Ltd. et al.
US10335462	March, 2024	Terminated-Settled	Novo Nordisk A/S	Apotex Inc. et al.
US10335462	November, 2023	Trial Instituted	Novo Nordisk A/S	Sun Pharmaceutical Industries Ltd. et al.
US10335462	October, 2023	Trial Instituted	Novo Nordisk A/S	DR. REDDY'S LABORATORIES, INC. et al.
US10335462	March, 2023	Trial Instituted	Novo Nordisk A/S	Mylan Pharmaceuticals Inc. et al.
US8129343	March, 2023	Institution Denied	Novo Nordisk A/S	Mylan Pharmaceuticals Inc. et al.
US8536122	March, 2023	Institution Denied	Novo Nordisk A/S	Mylan Pharmaceuticals Inc. et al.
US8114833	March, 2022	Terminated-Settled	Novo Nordisk A/S	Fresenius Kabi USA, LLC
US8114833	December, 2019	Terminated-Settled	Novo Nordisk A/S et al.	Pfizer Inc. et al.
US8114833	July, 2020	Terminated-Settled	Novo Nordisk A/S	Pfizer Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8536122	NOVO	Acylated GLP-1 compounds	Mar, 2026 (2 months from now)
US8129343	NOVO	Acylated GLP-1 compounds	Dec, 2031 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9486588	NOVO	Automatic injection device with reset feature	Jan, 2022 (4 years ago)
US8579869	NOVO	Needle mounting system and a method for mounting a needle assembly	Jun, 2023 (2 years ago)
US8672898	NOVO	Automatic injection device with reset feature	Jan, 2022 (4 years ago)
US6899699	NOVO	Automatic injection device with reset feature	Jan, 2022 (4 years ago)
US12295988	NOVO	Semaglutide in medical therapy	Oct, 2038 (12 years from now)
US7762994	NOVO	Needle mounting system and a method for mounting a needle assembly	May, 2024 (1 year, 7 months ago)
US10357616	NOVO	Injection device with an end of dose feedback mechanism	Jan, 2026 (10 days from now)
US10335462	NOVO	Use of long-acting GLP-1 peptides	Jun, 2033 (7 years from now)
US11311679	NOVO	Automatic injection device with a top release mechanism	Jan, 2026 (10 days from now)
US11446443	NOVO	Injection device with torsion spring and rotatable display	Oct, 2025 (2 months ago)
US8684969	NOVO	Injection device with torsion spring and rotatable display	Oct, 2025 (2 months ago)
US9108002	NOVO	Automatic injection device with a top release mechanism	Jan, 2026 (10 days from now)
US11097063	NOVO	Syringe device with a dose limiting mechanism and an additional safety mechanism	Jul, 2026 (6 months from now)
US9775953	NOVO	Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left	Jul, 2026 (6 months from now)
US10376652	NOVO	Automatic injection device with a top release mechanism	Jan, 2026 (10 days from now)
US8920383	NOVO	Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left	Jul, 2026 (6 months from now)
US9861757	NOVO	Injection device with an end of dose feedback mechanism	Jan, 2026 (10 days from now)
US9616180	NOVO	Automatic injection device with a top release mechanism	Jan, 2026 (10 days from now)
USRE46363	NOVO	Dial-down mechanism for wind-up pen	Aug, 2026 (6 months from now)
US9457154	NOVO	Injection device with an end of dose feedback mechanism	Sep, 2027 (1 year, 8 months from now)
US9687611	NOVO	Injection device with torsion spring and rotatable display	Feb, 2027 (1 year, 1 month from now)
US10220155	NOVO	Syringe device with a dose limiting mechanism and an additional safety mechanism	Jul, 2026 (6 months from now)
US8114833	NOVO	Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices	Aug, 2025 (4 months ago)
US9132239	NOVO	Dial-down mechanism for wind-up pen	Feb, 2032 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 05, 2022
New Indication(I-822)	Jan 16, 2023
New Dosing Schedule(D-185)	Mar 28, 2025
New Indication(I-961)	Jan 28, 2028

Drugs and Companies using SEMAGLUTIDE ingredient

NCE-1 date: 05 December, 2021

Market Authorisation Date: 05 December, 2017

Dosage: SOLUTION

OZEMPIC family patents

34. Pradaxa patent expiration

Treatment: Inhibition of thrombin; Method of reversing the anticoagulant effect of dabigatran using idarucizumab; Treatment of venous thrombotic disease

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6087380	BOEHRINGER INGELHEIM	Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions	Dec, 2021 (4 years ago)
US7932273	BOEHRINGER INGELHEIM	3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament	Sep, 2025 (4 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7866474 (Pediatric)	BOEHRINGER INGELHEIM	Film container	Mar, 2028 (2 years from now)
US6087380	BOEHRINGER INGELHEIM	Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions	Feb, 2018 (7 years ago)
US9925174	BOEHRINGER INGELHEIM	Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof	Jun, 2023 (2 years ago)
US7866474	BOEHRINGER INGELHEIM	Film container	Aug, 2027 (1 year, 7 months from now)
US6087380 (Pediatric)	BOEHRINGER INGELHEIM	Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions	Jun, 2022 (3 years ago)
US9925174 (Pediatric)	BOEHRINGER INGELHEIM	Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof	Dec, 2023 (2 years ago)
US9034822	BOEHRINGER INGELHEIM	Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds	Jan, 2031 (5 years from now)
US7932273 (Pediatric)	BOEHRINGER INGELHEIM	3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament	Mar, 2026 (a month from now)
US9034822 (Pediatric)	BOEHRINGER INGELHEIM	Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds	Jul, 2031 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 19, 2015
New Indication(I-682)	Apr 04, 2017
New Indication(I-683)	Apr 04, 2017
M(M-168)	Nov 20, 2018
New Strength(NS)	Nov 20, 2018
New Indication(I-862)	Jun 21, 2024
New Product(NP)	Jun 21, 2024
Pediatric Exclusivity(PED)	Dec 21, 2024

Drugs and Companies using DABIGATRAN ETEXILATE MESYLATE ingredient

Market Authorisation Date: 21 June, 2021

Dosage: PELLETS; CAPSULE

PRADAXA family patents

35. Ranexa patent expiration

Treatment: Treating chronic angina by administering an extended release form of ranolazine

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6369062	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6503911	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6617328	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6525057	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6479496	MENARINI INTL	Methods for treating angina with ranolazine	May, 2019 (6 years ago)
US6620814	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6864258	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6562826	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6852724	MENARINI INTL	Sustained release ranolazine formulations	May, 2019 (6 years ago)
US6303607	MENARINI INTL	Method for administering a sustained release ranolanolazine formulation	May, 2019 (6 years ago)

Drugs and Companies using RANOLAZINE ingredient

Market Authorisation Date: 12 February, 2007

Dosage: TABLET, EXTENDED RELEASE

RANEXA family patents

36. Rapiblyk patent expiration

Treatment: A method of reducing the heart rate of a subject suffering from supraventricular tachycardia, wherein landiolol is administered parenterally at a constant dose of more than 20 mcg/kg/min for 2-20 hour...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10722516	AOP HLTH US	NA	Apr, 2034 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 22, 2029

Drugs and Companies using LANDIOLOL HYDROCHLORIDE ingredient

NCE-1 date: 22 November, 2028

Market Authorisation Date: 22 November, 2024

Dosage: POWDER

RAPIBLYK family patents

37. Remodulin patent expiration

Treatment: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration; Treatment of pulmonary hypertension wit...

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9604901	March, 2020	Final Written Decision	United Therapeutics Corp.	Liquidia Technolgies, Inc.
US9604901	March, 2020	FWD Entered	United Therapeutics Corp.	Liquidia Technolgies, Inc.
US9593066	March, 2020	Institution Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US9593066	March, 2020	Terminated-Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US8497393	October, 2015	Final Written Decision	United Therapeutics Corporation	SteadyMed Ltd. et al.
US8497393	October, 2015	FWD Entered	United Therapeutics Corporation	SteadyMed Ltd.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8497393	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (2 years from now)
US9593066	UNITED THERAP	Process to prepare treprostinil, the active ingredient in remodulin®	Dec, 2028 (2 years from now)
US11723887	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (2 years from now)
US9604901	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (2 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8658694	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Sep, 2028 (2 years from now)
US5153222	UNITED THERAP	Method of treating pulmonary hypertension with benzidine prostaglandins	Oct, 2014 (11 years ago)
US6765117	UNITED THERAP	Process for stereoselective synthesis of prostacyclin derivatives	Oct, 2017 (8 years ago)
US8653137	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Sep, 2028 (2 years from now)
US7999007	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Mar, 2029 (3 years from now)
US9199908	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (1 year, 7 months ago)
US9713599	UNITED THERAP	Parenteral formulations of treprostinil	Dec, 2024 (1 year, 24 days ago)
US10695308	UNITED THERAP	Inhalation formulations of treprostinil	Dec, 2024 (1 year, 24 days ago)
US10076505	UNITED THERAP	Inhalation formulations of Treprostinil	Dec, 2024 (1 year, 24 days ago)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 28 September, 2023

Dosage: INJECTABLE; SOLUTION

REMODULIN family patents

38. Samsca patent expiration

Treatment: Method of treating hyponatremia

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8501730	OTSUKA	Process for preparing benzazepine compounds or salts thereof	Sep, 2026 (7 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5753677	OTSUKA	Benzoheterocyclic compounds	May, 2015 (10 years ago)
US5258510	OTSUKA	Benzoheterocyclic compounds	Nov, 2012 (13 years ago)
US10905694	OTSUKA	Pharmaceutical solid preparation comprising benzazepines and production method thereof	Apr, 2030 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 19, 2014

Drugs and Companies using TOLVAPTAN ingredient

NCE-1 date: 19 May, 2013

Market Authorisation Date: 19 May, 2009

Dosage: TABLET

SAMSCA family patents

39. Tikosyn patent expiration

Treatment: Treatment of cardiac arrhythmia

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US4959366	PFIZER	Anti-arrhythmic agents	Sep, 2012 (13 years ago)
US6124363	PFIZER	Dofetilide polymorphs	Oct, 2018 (7 years ago)

Drugs and Companies using DOFETILIDE ingredient

Market Authorisation Date: 01 October, 1999

Dosage: CAPSULE

TIKOSYN family patents

40. Tracleer patent expiration

Treatment: NA

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5292740	ACTELION	Sulfonamides	Nov, 2015 (10 years ago)
US8309126	ACTELION	Dispersible bosentan tablet	May, 2026 (4 months from now)
US7959945	ACTELION	Dispersible bosentan tablet	Dec, 2027 (1 year, 11 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-607)	Aug 07, 2012
New Product(NP)	Sep 05, 2020
New Patient Population(NPP)	Sep 05, 2020
Orphan Drug Exclusivity(ODE)	Sep 05, 2024
ODE(ODE)	Sep 05, 2024
Orphan Drug Exclusivity(ODE-161)	Sep 05, 2024

Drugs and Companies using BOSENTAN ingredient

Market Authorisation Date: 20 November, 2001

Dosage: TABLET; TABLET, FOR SUSPENSION

TRACLEER family patents

41. Tryvio patent expiration

Treatment: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin converting enzyme inhibitor, to lower blood pressure in adult patients who are not adequately contr...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8324232	IDORSIA	4-pyrimidinesulfamide derivative	Sep, 2029 (3 years from now)
US10919881	IDORSIA	Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan	Feb, 2038 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11787782	IDORSIA	Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases	Mar, 2038 (12 years from now)
US11680058	IDORSIA	Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan	Jul, 2038 (12 years from now)
US11174247	IDORSIA	Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases	Nov, 2037 (11 years from now)
US12297189	IDORSIA	Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan	Feb, 2038 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Mar 22, 2029

Drugs and Companies using APROCITENTAN ingredient

NCE-1 date: 22 March, 2028

Market Authorisation Date: 19 March, 2024

Dosage: TABLET

TRYVIO family patents

42. Uptravi patent expiration

Treatment: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan; Method of treating pulmonary arterial hypertens...

Application	Filing Date	Opposition Party	Legal Status

EP17186415A	2020-10-15	Generics [UK] Limited	Granted and Under Opposition
EP17191033A	2020-07-09	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP17191033A	2020-07-09	Generics (UK) Ltd	Granted and Under Opposition
EP17191033A	2020-07-06	Aera A/S	Granted and Under Opposition
EP10792183A	2018-09-05	Hexal AG	Granted and Under Opposition
EP10792183A	2018-09-04	Generics [UK] Ltd	Granted and Under Opposition
EP10792183A	2018-09-03	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP09786912A	2018-07-25	Hexal AG	Granted and Under Opposition
EP09786912A	2018-07-24	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09786912A	2018-07-24	STADA Arzneimittel AG	Granted and Under Opposition
EP09786912A	2018-07-23	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP09786912A	2018-07-19	Generics (UK) Ltd	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7205302	ACTELION	Heterocyclic compound derivatives and medicines	Oct, 2026 (9 months from now)
US8791122	ACTELION	Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide and method for producing the same	Aug, 2030 (4 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9173881	ACTELION	Therapeutic compositions containing macitentan	Aug, 2029 (3 years from now)
US9284280	ACTELION	Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide	Jun, 2030 (4 years from now)
US10828298	ACTELION	Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsulfonyl)acetamide	Dec, 2036 (10 years from now)
US10821108	ACTELION	Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide	Dec, 2036 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 21, 2020
Orphan Drug Exclusivity(ODE)	Dec 21, 2022
Orphan Drug Exclusivity(ODE-106)	Dec 21, 2022

Drugs and Companies using SELEXIPAG ingredient

NCE-1 date: 22 December, 2019

Market Authorisation Date: 21 December, 2015

Dosage: TABLET; POWDER

UPTRAVI family patents

43. Verquvo patent expiration

Treatment: Reducing the risk of cardiovascular death and heart failure (hf) hospitalization following a hospitalization for hf or need for outpatient i...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9604948	MSD	Process for preparing substituted 5-fluoro-1H-pyrazolopyridines	Nov, 2032 (6 years from now)
US10736896	MSD	Substituted 5-fluoro-1H-pyrazolopyridines and their use	May, 2031 (5 years from now)
US8420656	MSD	Substituted 5-fluoro-1H-pyrazolopyridines and their use	May, 2031 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9993476	MSD	Substituted 5-flouro-1H-pyrazolopyridines and their use	May, 2031 (5 years from now)
US8921377	MSD	Substituted 5-fluoro-1H-pyrazolopyridines and their use	May, 2031 (5 years from now)
US11439642	MSD	Substituted 5-fluoro-1H-pyrazolopyridines and their use	May, 2031 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 19, 2026

Drugs and Companies using VERICIGUAT ingredient

NCE-1 date: 19 January, 2025

Market Authorisation Date: 19 January, 2021

Dosage: TABLET

VERQUVO family patents

44. Vyndaqel patent expiration

Treatment: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (attr-cm)

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8168663	FOLDRX PHARMS	Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof	Dec, 2023 (2 years ago)
US7214695	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2026 (11 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8653119	FOLDRX PHARMS	Methods for treating transthyretin amyloid diseases	Dec, 2023 (2 years ago)
US7214696	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2026 (11 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 03, 2024
Orphan Drug Exclusivity(ODE-237)	May 03, 2026

Drugs and Companies using TAFAMIDIS MEGLUMINE ingredient

NCE-1 date: 04 May, 2023

Market Authorisation Date: 03 May, 2019

Dosage: CAPSULE

VYNDAQEL family patents

45. Welchol patent expiration

Treatment: Use as a bile acid sequestrant for lowering cholesterol; A method for reducing serum glucose levels in adults with type 2 diabetes mellitus; Use as a bile acid sequestrant

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5693675	COSETTE	Alkylated amine polymers	Dec, 2014 (11 years ago)
US6784254	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Apr, 2014 (11 years ago)
US6433026	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Apr, 2014 (11 years ago)
US5607669	COSETTE	Amine polymer sequestrant and method of cholesterol depletion	Jun, 2014 (11 years ago)
US5679717	COSETTE	Method for removing bile salts from a patient with alkylated amine polymers	Apr, 2014 (11 years ago)
US7229613	COSETTE	Method for lowering serum glucose	Apr, 2022 (3 years ago)
US6066678	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Apr, 2014 (11 years ago)
US5919832	COSETTE	Amine polymer sequestrant and method of cholesterol depletion	Apr, 2014 (11 years ago)
US5917007	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Apr, 2014 (11 years ago)
US7101960	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Apr, 2014 (11 years ago)
US5917007 (Pediatric)	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Oct, 2014 (11 years ago)
US5693675 (Pediatric)	COSETTE	Alkylated amine polymers	Jun, 2015 (10 years ago)
US5679717 (Pediatric)	COSETTE	Method for removing bile salts from a patient with alkylated amine polymers	Oct, 2014 (11 years ago)
US6066678 (Pediatric)	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Oct, 2014 (11 years ago)
US5607669 (Pediatric)	COSETTE	Amine polymer sequestrant and method of cholesterol depletion	Dec, 2014 (11 years ago)
US5919832 (Pediatric)	COSETTE	Amine polymer sequestrant and method of cholesterol depletion	Oct, 2014 (11 years ago)
US6433026 (Pediatric)	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Oct, 2014 (11 years ago)
US6784254 (Pediatric)	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Oct, 2014 (11 years ago)
US7101960 (Pediatric)	COSETTE	Process for removing bile salts from a patient and alkylated compositions therefor	Oct, 2014 (11 years ago)
US7229613 (Pediatric)	COSETTE	Method for lowering serum glucose	Oct, 2022 (3 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-608)	Oct 02, 2012
Pediatric Exclusivity(PED)	Apr 02, 2013
M(M-232)	Oct 20, 2024

Drugs and Companies using COLESEVELAM HYDROCHLORIDE ingredient

Market Authorisation Date: 26 May, 2000

Dosage: CAPSULE; FOR SUSPENSION; TABLET; BAR, CHEWABLE

WELCHOL family patents

46. Xarelto patent expiration

Treatment: Reduction in the risk of recurrence of deep vein thrombosis (dvt) and pulmonary embolism; Prophylaxis of deep vein thrombosis (dvt); Treatment of venous thromboembolism (vte) and the reduction in the ...

Application	Filing Date	Opposition Party	Legal Status

EP06706291A	2021-04-14	Krka, d.d., Novo mesto	Opposition rejected
EP06706291A	2021-03-19	Zentiva Group, a.s.	Opposition rejected
EP06706291A	2016-01-26	ABG Patentes, S.L.	Opposition rejected
EP06706291A	2016-01-22	Kraus & Weisert Patentanwälte PartGmbB	Opposition rejected
EP06706291A	2016-01-22	Hexal AG	Opposition rejected
EP06706291A	2016-01-22	Galenicum Health S.L.	Opposition rejected
EP06706291A	2016-01-22	Stolmár, Matthias	Opposition rejected
EP06706291A	2016-01-21	Wittkopp, Alexander	Opposition rejected
EP06706291A	2016-01-21	Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi	Opposition rejected
EP06706291A	2016-01-21	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Opposition rejected
EP06706291A	2016-01-21	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP06706291A	2016-01-21	STADA Arzneimittel AG	Opposition rejected
EP06706291A	2016-01-21	Generics [UK] Limited (trading as Mylan)	Opposition rejected
EP06706291A	2016-01-06	Actavis Group PTC ehf	Opposition rejected
EP06706291A	2015-07-22	Breuer, Markus	Opposition rejected
EP2006000431W	2012-01-20	Spanolux N.V.- DIV. Balterio	Opposition rejected
EP04797879A	2008-11-12	Ratiopharm GmbH	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10828310	February, 2022	Final Written Decision - Appealed	Bayer Pharma AG et al.	Mylan Pharmaceuticals Inc. et al.
US10828310	September, 2022	Final Written Decision	Bayer Pharma AG et al.	InvaGen Pharmaceuticals, Inc. et al.
US10828310	September, 2022	Final Written Decision - Appealed	Bayer Pharma AG et al.	InvaGen Pharmaceuticals, Inc. et al.
US10828310	September, 2022	Final Written Decision	Bayer Pharma AG et al.	Teva Pharmaceuticals USA, Inc
US10828310	September, 2022	Final Written Decision - Appealed	Bayer Pharma AG et al.	Teva Pharmaceuticals USA, Inc
US9539218	May, 2018	Institution Denied	Bayer Intellectual Property GmbH et al.	Mylan Pharmaceuticals Inc. et al.
US9539218	May, 2018	Terminated-Denied	Bayer Intellectual Property GmbH	Mylan Pharmaceuticals Inc.
US7157456	October, 2016	Terminated	Bayer Intellectual Property GmbH et al.	Mylan Pharmaceuticals Inc et al.
US7585860	October, 2016	Terminated	Bayer Intellectual Property GmbH et al.	Mylan Pharmaceuticals Inc. et al.
US7592339	October, 2016	Terminated	Bayer Intellectual Property GmbH et al.	Mylan Pharmaceuticals Inc. et al.
US9539218	January, 2014	Decision	Frank Misselwitz et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7585860	JANSSEN PHARMS	Substituted oxazolidinones and their use in the field of blood coagulation	Dec, 2020 (5 years ago)
US7157456	JANSSEN PHARMS	Substituted oxazolidinones and their use in the field of blood coagulation	Aug, 2024 (1 year, 4 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7585860	JANSSEN PHARMS	Substituted oxazolidinones and their use in the field of blood coagulation	Dec, 2020 (5 years ago)
US7592339	JANSSEN PHARMS	Substituted oxazolidinones and their use in the field of blood coagulation	Dec, 2020 (5 years ago)
US9415053	JANSSEN PHARMS	Solid, orally administrable pharmaceutical composition	Nov, 2024 (1 year, 1 month ago)
US9539218	JANSSEN PHARMS	Prevention and treatment of thromboembolic disorders	Feb, 2034 (8 years from now)
US10828310	JANSSEN PHARMS	Reducing the risk of cardiovascular events	Jan, 2039 (13 years from now)
US7157456 (Pediatric)	JANSSEN PHARMS	Substituted oxazolidinones and their use in the field of blood coagulation	Feb, 2025 (10 months ago)
US9415053 (Pediatric)	JANSSEN PHARMS	Solid, orally administrable pharmaceutical composition	May, 2025 (7 months ago)
US9539218 (Pediatric)	JANSSEN PHARMS	Prevention and treatment of thromboembolic disorders	Aug, 2034 (8 years from now)
US10828310 (Pediatric)	JANSSEN PHARMS	Reducing the risk of cardiovascular events	Jul, 2039 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-643)	Nov 04, 2014
New Indication(I-660)	Nov 02, 2015
New Indication(I-661)	Nov 02, 2015
New Indication(I-662)	Nov 02, 2015
New Chemical Entity Exclusivity(NCE)	Jul 01, 2016
New Dosing Schedule(D-168)	Oct 27, 2020
New Indication(I-824)	Oct 11, 2021
New Indication(I-810)	Oct 11, 2022
M(M-284)	Mar 10, 2023
New Indication(I-867)	Aug 23, 2024
New Product(NP)	Dec 20, 2024
Pediatric Exclusivity(PED)	Jun 20, 2025

Drugs and Companies using RIVAROXABAN ingredient

NCE-1 date: 24 February, 2024

Market Authorisation Date: 11 October, 2018

Dosage: TABLET; FOR SUSPENSION

XARELTO family patents

47. Zetia patent expiration

Treatment: To reduce elevated total-c, ldl-c, apo b and non-hdl-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate; To reduce plasm...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5846966 (Pediatric)	ORGANON	Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors	Mar, 2014 (11 years ago)
USRE42461	ORGANON	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents	Oct, 2016 (9 years ago)
USRE37721	ORGANON	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents	Oct, 2016 (9 years ago)
USRE42461 (Pediatric)	ORGANON	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents	Apr, 2017 (8 years ago)
USRE37721 (Pediatric)	ORGANON	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents	Apr, 2017 (8 years ago)
US7030106	ORGANON	Sterol absorption inhibitor compositions	Jan, 2022 (3 years ago)
US7030106 (Pediatric)	ORGANON	Sterol absorption inhibitor compositions	Jul, 2022 (3 years ago)
US5846966	ORGANON	Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors	Sep, 2013 (12 years ago)
US7612058	ORGANON	Methods for inhibiting sterol absorption	Oct, 2025 (2 months ago)
US7612058 (Pediatric)	ORGANON	Methods for inhibiting sterol absorption	Apr, 2026 (3 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Dec 05, 2011
M(M-109)	Jan 24, 2015

Drugs and Companies using EZETIMIBE ingredient

Market Authorisation Date: 25 October, 2002

Dosage: TABLET

ZETIA family patents

48. Zontivity patent expiration

Treatment: Reduction of thrombotic cardiovascular events; Reduction of thrombotic cardiovascular

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7235567	KEY THERAP	Crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist	Jun, 2021 (4 years ago)
US7304078	KEY THERAP	Thrombin receptor antagonists	Dec, 2027 (1 year, 11 months from now)
US7713999	KEY THERAP	Thrombin receptor antagonists	May, 2024 (1 year, 7 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 08, 2019

Drugs and Companies using VORAPAXAR SULFATE ingredient

NCE-1 date: 08 May, 2018

Market Authorisation Date: 08 May, 2014

Dosage: TABLET

Strength	Dosage	Availability
EQ 40MG BASE	TABLET	Prescription
EQ 5MG BASE	TABLET	Prescription
EQ 10MG BASE	TABLET	Prescription
EQ 20MG BASE	TABLET	Prescription

Strength	Dosage	Availability
EQ 80MG MEDOXOMIL	TABLET	Prescription
EQ 40MG MEDOXOMIL	TABLET	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9326945	April, 2018	Terminated-Settled	Pfizer Inc.	Mylan Pharmaceuticals Inc.
US6967208	August, 2015	Institution Denied	Bristol-Myers Squibb Company	Coalition for Affordable Drugs IX, LLC et al.
US6967208	August, 2015	Terminated-Denied	Bristol-Myers Squibb Company	Coalition for Affordable Drugs IX, LLC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg and 50 mg	27 Sep, 2006	2	30 Jul, 2008	10 Apr, 2020	Eligible
0.75 mg/mL, 100 mL vial	05 Jun, 2009	1	05 Jun, 2015	15 Sep, 2015	Eligible

Strength	Dosage	Availability
50MG	TABLET	Prescription
100MG	TABLET	Discontinued
25MG	TABLET	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP05724887A	2013-08-21	Stein, Evan MD PhD	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent

US7015315	September, 2004	Decision	COOK et al
US7015315	October, 2000	Decision	COOK et al

Application	Filing Date	Opposition Party	Legal Status

EP11833507A	2017-12-22	SANDOZ AG	Revoked
EP11833507A	2017-12-21	Zentiva Group, a.s.	Revoked
EP11833507A	2017-12-21	Generics (U.K.) Limited	Revoked
EP11833507A	2017-12-21	Teva Pharmaceutical Industries Ltd	Revoked
EP11833507A	2017-12-20	STADA Arzneimittel AG	Revoked
EP11833507A	2017-12-20	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP07855065A	2016-02-19	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP07855065A	2016-02-18	TEVA PHARMACEUTICAL INDUSTRIES, LTD.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US5856336	July, 2015	Institution Denied	Nissan Chemical Industries Ltd. et al.	Sawai USA, Inc. et al.
US5856336	July, 2015	Terminated-Denied	Nissan Chemical Industries Ltd.	Sawai USA, Inc.
US5856336	April, 2015	Institution Denied	Nissan Chemical Industries, Ltd. et al.	Mylan Pharmaceuticals Inc.
US5856336	April, 2015	Terminated-Denied	Nissan Chemical Industries, Ltd.	Mylan Pharmaceuticals Inc.

Strength	Dosage	Availability
EQ 1MG BASE	TABLET	Prescription
EQ 4MG BASE	TABLET	Prescription
EQ 2MG BASE	TABLET	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8268847	June, 2025	Pending	Actelion Pharmaceuticals Ltd. et al.	United Therapeutics Corporation

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2 mg/1.5 mL and 4 mg/3 mL	06 Dec, 2021	7		21 Jun, 2033
8 mg/3 mL	21 Dec, 2022	1		01 Feb, 2032

Strength	Dosage	Availability
4MG/3ML (1.34MG/ML)	SOLUTION	Prescription
2MG/3ML (0.68MG/ML)	SOLUTION	Prescription
2MG/1.5ML (1.34MG/ML)	SOLUTION	Discontinued
8MG/3ML (2.68MG/ML)	SOLUTION	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP03743368A	2013-04-03	Sanovel IIaç San. ve Tic. A.S.	Patent maintained as amended
EP03743368A	2013-03-27	Stötter, Gerd	Patent maintained as amended
EP07115663A	2012-10-10	Sanovel IIaç San. ve Tic. A.S.	Revoked
EP07115663A	2012-10-05	Stötter, Gerd	Revoked
EP09153155A	2012-07-13	PONS PATENTES Y MARCAS INTERNACIONAL, S.L.	Revoked
EP09153155A	2012-07-12	Sanovel Ilac Sanayii ve Ticaret A.S.	Revoked
EP09153155A	2012-07-06	Stötter, Gerd	Revoked
EP04764411A	2010-01-29	APOTEX INC.	Opposition rejected

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
eq. to 75 mg base and 150 mg base	20 Oct, 2014	17	06 May, 2020	31 Aug, 2027	Eligible
eq. to 110 mg base	15 Dec, 2015	2		20 Jan, 2031

Strength	Dosage	Availability
EQ 20MG BASE/PACKET	PELLETS	Prescription
EQ 30MG BASE/PACKET	PELLETS	Prescription
EQ 40MG BASE/PACKET	PELLETS	Prescription
EQ 75MG BASE	CAPSULE	Prescription
EQ 150MG BASE	CAPSULE	Prescription
EQ 110MG BASE	CAPSULE	Prescription
EQ 150MG BASE/PACKET	PELLETS	Prescription
EQ 110MG BASE/PACKET	PELLETS	Prescription
EQ 50MG BASE/PACKET	PELLETS	Prescription

Strength	Dosage	Availability
1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE	Discontinued
500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE	Discontinued

Application	Filing Date	Opposition Party	Legal Status

EP13188882A	2019-12-05	Generics [UK] Ltd	Revoked
EP13188882A	2019-11-22	Teva Pharmaceutical Industries Ltd	Revoked
EP04776104A	2017-10-25	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP08829225A	2016-10-06	Generics (U.K.) Limited	Revoked
EP08829225A	2016-09-30	Teva Pharmaceutical Industries Ltd	Revoked

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg/mL, 20 mL vial	02 Dec, 2011	1	30 Nov, 2017	29 Mar, 2029	Eligible
1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	07 Dec, 2012	1	30 Nov, 2017	29 Mar, 2029	Eligible

Strength	Dosage	Availability
10MG/ML	INJECTABLE	Prescription
1MG/ML	INJECTABLE	Prescription
5MG/ML	INJECTABLE	Prescription
2.5MG/ML	INJECTABLE	Prescription
50MG/20ML (2.5MG/ML)	SOLUTION	Discontinued
0.1MG/ML	INJECTABLE	Discontinued
0.2MG/ML	INJECTABLE	Discontinued
0.4MG/ML	INJECTABLE	Prescription
20MG/ML	INJECTABLE	Discontinued
200MG/20ML (10MG/ML)	SOLUTION	Discontinued
100MG/20ML (5MG/ML)	SOLUTION	Discontinued
20MG/20ML (1MG/ML)	SOLUTION	Discontinued

Pharsight

Pharsight

Cardiovascular Therapeutics

1. Adempas patent expiration

ADEMPAS family patents

2. Angiomax patent expiration

ANGIOMAX family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years. Get the exclusive patent insights now. Don't be the last to know. Download Report 3. Attruby patent expiration

ATTRUBY family patents

4. Benicar patent expiration

BENICAR family patents

5. Bevyxxa patent expiration

BEVYXXA family patents

6. Brenzavvy patent expiration

BRENZAVVY family patents

7. Brilinta patent expiration

BRILINTA family patents

8. Bystolic patent expiration

BYSTOLIC family patents

9. Camzyos patent expiration

CAMZYOS family patents

10. Cialis patent expiration

CIALIS family patents

11. Cleviprex patent expiration

CLEVIPREX family patents

12. Corlanor patent expiration

CORLANOR family patents

13. Corlanor patent expiration

CORLANOR family patents

14. Crestor patent expiration

CRESTOR family patents

15. Definity patent expiration

DEFINITY family patents

16. Edarbi patent expiration

EDARBI family patents

17. Effient patent expiration

EFFIENT family patents

18. Eliquis patent expiration

ELIQUIS family patents

19. Inpefa patent expiration

INPEFA family patents

20. Inspra patent expiration

INSPRA family patents

21. Jardiance patent expiration

JARDIANCE family patents

22. Juxtapid patent expiration

JUXTAPID family patents

23. Kengreal patent expiration

KENGREAL family patents

24. Kynamro patent expiration

KYNAMRO family patents

25. Leqvio patent expiration

LEQVIO family patents

26. Letairis patent expiration

LETAIRIS family patents

27. Lexiscan patent expiration

LEXISCAN family patents

28. Livalo patent expiration

LIVALO family patents

29. Multaq patent expiration

MULTAQ family patents

30. Natrecor patent expiration

NATRECOR family patents

31. Nexletol patent expiration

NEXLETOL family patents

32. Opsumit patent expiration

OPSUMIT family patents

33. Ozempic patent expiration

What is Ozempic?

What is the Ozempic controversy?

OZEMPIC family patents

34. Pradaxa patent expiration

PRADAXA family patents

35. Ranexa patent expiration

RANEXA family patents

36. Rapiblyk patent expiration

RAPIBLYK family patents

37. Remodulin patent expiration

REMODULIN family patents

38. Samsca patent expiration

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

3. Attruby patent expiration

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
30mg	23 Sep, 2013	1		19 May, 2020	Extinguished Non-Forfeiture
15 mg	10 Oct, 2013	1	15 Feb, 2022	01 Sep, 2026	Non-Forfeiture
60 mg	26 Mar, 2018	1	19 May, 2020	01 Sep, 2026	Eligible

Strength	Dosage	Availability
62.5MG	TABLET	Prescription
125MG	TABLET	Prescription
32MG	TABLET, FOR SUSPENSION	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg	23 Dec, 2019	4	21 Dec, 2022	01 Aug, 2030	Eligible
1.8 mg/vial	29 Jul, 2022	1		01 Aug, 2030

Strength	Dosage	Availability
0.2MG	TABLET	Prescription
0.6MG	TABLET	Prescription
0.8MG	TABLET	Prescription
1MG	TABLET	Prescription
1.2MG	TABLET	Prescription
1.6MG	TABLET	Prescription
0.4MG	TABLET	Prescription
1.8MG/VIAL	POWDER	Prescription
1.4MG	TABLET	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1.875 g/Packet and 3.75 g/Packet	09 Apr, 2010	1		02 Dec, 2014	Extinguished
625 mg	01 Jul, 2009	1	16 May, 2018	10 Dec, 2014	Extinguished

Strength	Dosage	Availability
375MG	CAPSULE	Discontinued
1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	Discontinued
625MG	TABLET	Prescription
3.75GM/PACKET	FOR SUSPENSION	Prescription
3.75GM	BAR, CHEWABLE	Discontinued

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
2.5 mg	19 Nov, 2018	4	13 Nov, 2024
10 mg, 15 mg, and 20 mg	01 Jul, 2015	8	28 Aug, 2024
10 mg, 15 mg and 20 mg	17 Jun, 2022	1	17 Feb, 2034

Application	Filing Date	Opposition Party	Legal Status

EP02770534A	2009-07-14	TEVA PHARMACEUTICAL INDUSTRIES LTD.	Opposition procedure closed
EP02707500A	2008-02-22	EGIS Gyógyszergyár Nyrt	Revoked