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 clinic...

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. 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

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

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3. Inomax patent expiration

Treatment: A method of providing nitric oxide therapy to a patient; A method of purging a nitric oxide delivery system; Prevention or treatment of reversible vasoconstriction by the inhalation of nitric oxide wi...

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8282966	March, 2016	Institution Denied	Mallinckrodt Hospital Products IP Ltd. et al.	Praxair Distribution, Inc. et al.
US8282966	March, 2016	Terminated-Denied	Mallinckrodt Hospital Products IP Ltd.	Praxair Distribution, Inc.
US8293284	March, 2016	Institution Denied	Mallinckrodt Hospital Products IP Ltd. et al.	Praxair Distribution, Inc. et al.
US8293284	March, 2016	Terminated-Denied	Mallinckrodt Hospital Products IP Ltd.	Praxair Distribution, Inc.
US8431163	March, 2016	Institution Denied	Mallinckrodt Hospital Products IP Ltd. et al.	Praxair Distribution, Inc. et al.
US8431163	March, 2016	Terminated-Denied	Mallinckrodt Hospital Products IP Ltd.	Praxair Distribution, Inc.
US8795741	March, 2016	Institution Denied	Mallinckrodt Hospital Products IP Ltd. et al.	Praxair Distribution, Inc. et al.
US8795741	March, 2016	Terminated-Denied	Mallinckrodt Hospital Products IP Ltd.	Praxair Distribution, Inc.
US8776795	March, 2015	Final Written Decision	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8776795	March, 2015	FWD Entered	INO Therapeutics LLC	Praxair Distribution, Inc.
US8573209	March, 2015	Final Written Decision	INO THERAPEUTICS LLC et al.	Praxair Distribution, Inc. et al.
US8573209	March, 2015	FWD Entered	INO THERAPEUTICS LLC	Praxair Distribution, Inc.
US8573210	March, 2015	Final Written Decision	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8573210	March, 2015	FWD Entered	INO Therapeutics LLC	Praxair Distribution, Inc.
US8776794	March, 2015	Final Written Decision	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8776794	March, 2015	FWD Entered	INO Therapeutics LLC	Praxair Distribution, Inc.
US8291904	March, 2015	Final Written Decision	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8291904	March, 2015	FWD Entered	INO Therapeutics LLC	Praxair Distribution, Inc.
US8846112	March, 2016	Institution Denied	Mallinckrodt Hospital Products IP Ltd. et al.	Praxair Distribution, Inc. et al.
US8846112	March, 2016	Terminated-Denied	Mallinckrodt Hospital Products IP Ltd.	Praxair Distribution, Inc.
US8846112	January, 2015	Final Written Decision	INO THERAPEUTICS LLC et al.	Praxair Distribution, Inc. et al.
US8846112	January, 2015	FWD Entered	INO THERAPEUTICS LLC	Praxair Distribution, Inc.
US8282966	January, 2015	Institution Denied	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8282966	January, 2015	Terminated-Denied	INO Therapeutics LLC	Praxair Distribution, Inc.
US8293284	January, 2015	Institution Denied	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8293284	January, 2015	Terminated-Denied	INO Therapeutics LLC	Praxair Distribution, Inc.
US8431163	January, 2015	Institution Denied	INO THERAPEUTICS LLC et al.	Praxair Distribution, Inc. et al.
US8431163	January, 2015	Terminated-Denied	INO THERAPEUTICS LLC	Praxair Distribution, Inc.
US8795741	January, 2015	Institution Denied	INO Therapeutics LLC et al.	Praxair Distribution, Inc. et al.
US8795741	January, 2015	Terminated-Denied	INO Therapeutics LLC	Praxair Distribution, 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.
US11931377	MALLINCKRODT IRELAND	Methods of administering inhaled nitric oxide gas	Jun, 2029 (3 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).
US6125846 (Pediatric)	MALLINCKRODT IRELAND	Purge system for nitric oxide administration apparatus	Nov, 2017 (8 years ago)
US5732693	MALLINCKRODT IRELAND	Pause control of nitric oxide therapy	Dec, 2016 (9 years ago)
US5752504	MALLINCKRODT IRELAND	System for monitoring therapy during calibration	Dec, 2016 (9 years ago)
US6125846	MALLINCKRODT IRELAND	Purge system for nitric oxide administration apparatus	May, 2017 (8 years ago)
US5485827 (Pediatric)	MALLINCKRODT IRELAND	Methods and devices for treating plumonary vasoconstriction and asthma	Jul, 2013 (12 years ago)
US5558083 (Pediatric)	MALLINCKRODT IRELAND	Nitric oxide delivery system	May, 2014 (11 years ago)
US5873359 (Pediatric)	MALLINCKRODT IRELAND	Methods and devices for treating pulmonary vasoconstriction and asthma	Jul, 2013 (12 years ago)
US5873359	MALLINCKRODT IRELAND	Methods and devices for treating pulmonary vasoconstriction and asthma	Jan, 2013 (12 years ago)
US5752504 (Pediatric)	MALLINCKRODT IRELAND	System for monitoring therapy during calibration	Jun, 2017 (8 years ago)
US5732693 (Pediatric)	MALLINCKRODT IRELAND	Pause control of nitric oxide therapy	Jun, 2017 (8 years ago)
US8776795	MALLINCKRODT IRELAND	Gas delivery device and system	Jan, 2031 (4 years from now)
US8573210	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jan, 2031 (4 years from now)
US5558083	MALLINCKRODT IRELAND	Nitric oxide delivery system	Nov, 2013 (12 years ago)
US5485827	MALLINCKRODT IRELAND	Methods and devices for treating plumonary vasoconstriction and asthma	Jan, 2013 (12 years ago)
US9265911	MALLINCKRODT IRELAND	Gas delivery device and system	Jan, 2031 (4 years from now)
US9295802	MALLINCKRODT IRELAND	Gas delivery device and system	Jan, 2031 (4 years from now)
US8282966	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide	Jun, 2029 (3 years from now)
US8293284	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide	Jun, 2029 (3 years from now)
US8291904	MALLINCKRODT IRELAND	Gas delivery device and system	Jan, 2031 (4 years from now)
US8846112	MALLINCKRODT IRELAND	Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation	Jun, 2029 (3 years from now)
US8776794	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jan, 2031 (4 years from now)
US8795741	MALLINCKRODT IRELAND	Methods for treating patients who are candidates for inhaled nitric oxide treatment	Jun, 2029 (3 years from now)
US9279794	MALLINCKRODT IRELAND	Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide	Feb, 2035 (9 years from now)
US8431163	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas	Jun, 2029 (3 years from now)
US9408993	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jan, 2031 (4 years from now)
US9770570	MALLINCKRODT IRELAND	Apparatus and method for monitoring nitric oxide delivery	May, 2036 (10 years from now)
US8573209	MALLINCKRODT IRELAND	Gas delivery device and system	Jan, 2031 (4 years from now)
US8282966 (Pediatric)	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide	Dec, 2029 (3 years from now)
US8291904 (Pediatric)	MALLINCKRODT IRELAND	Gas delivery device and system	Jul, 2031 (5 years from now)
US8293284 (Pediatric)	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide	Dec, 2029 (3 years from now)
US8431163 (Pediatric)	MALLINCKRODT IRELAND	Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas	Dec, 2029 (3 years from now)
US8776795 (Pediatric)	MALLINCKRODT IRELAND	Gas delivery device and system	Jul, 2031 (5 years from now)
US8776794 (Pediatric)	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jul, 2031 (5 years from now)
US8795741 (Pediatric)	MALLINCKRODT IRELAND	Methods for treating patients who are candidates for inhaled nitric oxide treatment	Dec, 2029 (3 years from now)
US8573209 (Pediatric)	MALLINCKRODT IRELAND	Gas delivery device and system	Jul, 2031 (5 years from now)
US8846112 (Pediatric)	MALLINCKRODT IRELAND	Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation	Dec, 2029 (3 years from now)
US8573210 (Pediatric)	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jul, 2031 (5 years from now)
US9295802 (Pediatric)	MALLINCKRODT IRELAND	Gas delivery device and system	Jul, 2031 (5 years from now)
US9408993 (Pediatric)	MALLINCKRODT IRELAND	Nitric oxide delivery device	Jul, 2031 (5 years from now)
US9265911 (Pediatric)	MALLINCKRODT IRELAND	Gas delivery device and system	Jul, 2031 (5 years from now)
US9279794 (Pediatric)	MALLINCKRODT IRELAND	Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide	Aug, 2035 (9 years from now)
US11931377 (Pediatric)	MALLINCKRODT IRELAND	Methods of administering inhaled nitric oxide gas	Dec, 2029 (3 years from now)
US9770570 (Pediatric)	MALLINCKRODT IRELAND	Apparatus and method for monitoring nitric oxide delivery	Nov, 2036 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-132)	Dec 21, 2013
Pediatric Exclusivity(PED)	Jun 21, 2014
M(M-167)	Oct 09, 2018

Drugs and Companies using NITRIC OXIDE ingredient

Market Authorisation Date: 23 December, 1999

Dosage: GAS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 ppm and 800 ppm	20 May, 2014	1	02 Oct, 2018	06 Jan, 2031	Deferred

Strength	Dosage	Availability
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS	Discontinued
800PPM	GAS	Prescription
4880PPM	GAS	Prescription

INOMAX family patents

4. Letairis patent expiration

Treatment: Method to treat pulmonary hypertension by administering ambrisentan to a patient; Treatment of pulmonary arterial hypertension by inhibiting...

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

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, 11 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, 11 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

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	09 Feb, 2015	1	28 Mar, 2019	09 Jul, 2018	Extinguished

Strength	Dosage	Availability
5MG	TABLET	Prescription
10MG	TABLET	Prescription

LETAIRIS family patents

5. Opsumit patent expiration

Treatment: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhi...

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

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

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, 2 months 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

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg	18 Oct, 2017	11	06 Apr, 2021	18 Apr, 2029	Eligible

Strength	Dosage	Availability
10MG	TABLET	Prescription

OPSUMIT family patents

6. 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

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

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, 23 days ago)
US10695308	UNITED THERAP	Inhalation formulations of treprostinil	Dec, 2024 (1 year, 23 days ago)
US10076505	UNITED THERAP	Inhalation formulations of Treprostinil	Dec, 2024 (1 year, 23 days ago)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 28 September, 2023

Dosage: INJECTABLE; SOLUTION

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

REMODULIN family patents

7. 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

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
32 mg	08 Feb, 2019	1		28 Dec, 2027

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

TRACLEER family patents

8. 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

Pharsight

Pharsight

Pulmonary Hypertension Therapeutics

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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

Pharsight

Pharsight

Pulmonary Hypertension Therapeutics

1. Adempas patent expiration

ADEMPAS family patents

2. Cialis patent expiration

CIALIS 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. Inomax patent expiration

INOMAX family patents

4. Letairis patent expiration

LETAIRIS family patents

5. Opsumit patent expiration

OPSUMIT family patents

6. Remodulin patent expiration

REMODULIN family patents

7. Tracleer patent expiration

TRACLEER family patents

8. Uptravi patent expiration

UPTRAVI family patents

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Have Questions?

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. Inomax patent expiration