Pharsight

1. Amvuttra patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP17209680A	2023-01-27	AWA Sweden AB	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.
US10131907	ALNYLAM PHARMS INC	Glycoconjugates of RNA interference agents	Aug, 2028 (3 years from now)
US10806791	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (4 years from now)
US9370581	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (4 years from now)
US8828956	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (4 years from now)
US8106022	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (5 years from now)
US9399775	ALNYLAM PHARMS INC	RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases	Nov, 2032 (8 years from now)
US10570391	ALNYLAM PHARMS INC	RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases	Nov, 2032 (8 years from now)
US10612024	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (10 years from now)
US11401517	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (10 years from now)
US12049628	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (11 years from now)
US10683501	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (11 years from now)
US10208307	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (11 years from now)
US11286486	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 13, 2027
Orphan Drug Exclusivity(ODE-212)	Jun 13, 2029

Drugs and Companies using VUTRISIRAN SODIUM ingredient

NCE-1 date: 13 June, 2026

Market Authorisation Date: 13 June, 2022

Treatment: Amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Dosage: SOLUTION

Strength	Dosage	Availability
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION	Prescription

AMVUTTRA family patents

2. Baxdela patent expiration

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.
US9539250	MELINTA	Salt and crystalline forms thereof of a drug	Oct, 2025 (11 months from now)
US8273892	MELINTA	Salt and crystalline forms thereof of a drug	Aug, 2026 (1 year, 9 months from now)
US8871938	MELINTA	Process for making quinolone compounds	Sep, 2029 (4 years from now)
USRE46617	MELINTA	Process for making quinolone compounds	Dec, 2029 (5 years from now)
US8497378	MELINTA	Process for making quinolone compounds	Dec, 2029 (5 years from now)
US7728143	MELINTA	Salt and crystalline forms thereof of a drug	Jun, 2031 (6 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).
US8648093	MELINTA	Salt and crystalline forms thereof of a drug	Oct, 2025 (11 months from now)
US8969569	MELINTA	Salt and crystalline forms thereof of a drug	Oct, 2025 (11 months from now)
US8252813	MELINTA	Salt and crystalline forms thereof of a drug	Oct, 2026 (1 year, 11 months from now)
US7635773	MELINTA	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US8410077	MELINTA	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9200088	MELINTA	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9750822	MELINTA	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9493582	MELINTA	Alkylated cyclodextrin compositions and processes for preparing and using the same	Feb, 2033 (8 years from now)
US12036219	MELINTA	Methods of treating infections in overweight and obese patients using antibiotics	Jun, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 19, 2022
New Indication(I-815)	Oct 24, 2022
Generating Antibiotic Incentives Now(GAIN)	Jun 19, 2027

Drugs and Companies using DELAFLOXACIN MEGLUMINE ingredient

NCE-1 date: 19 June, 2026

Market Authorisation Date: 19 June, 2017

Treatment: Treatment of acute bacterial skin and skin structure infections caused by designated susceptible bacteria in adults; Treating an acute bacterial skin and skin structure infection (absssi) in an overwe...

Dosage: TABLET; POWDER

Strength	Dosage	Availability
EQ 450MG BASE	TABLET	Prescription
EQ 300MG BASE/VIAL	POWDER	Prescription

BAXDELA family patents

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3. Bludigo patent expiration

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.
US11845867	PROVEPHARM SAS	Process for the preparation of indigotindisulfonate sodium (indigo carmine)	Nov, 2036 (12 years from now)
US11499050	PROVEPHARM SAS	Process for the preparation of indigotindisulfonate sodium (indigo carmine)	Dec, 2037 (13 years from now)
US10927258	PROVEPHARM SAS	Process for the preparation of Indigotindisulfonate sodium (indigo carmine)	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 08, 2027

Drugs and Companies using INDIGOTINDISULFONATE SODIUM ingredient

NCE-1 date: 08 July, 2026

Market Authorisation Date: 08 July, 2022

Treatment: NA

Dosage: SOLUTION

Strength	Dosage	Availability
40MG/5ML (8MG/ML)	SOLUTION	Prescription

BLUDIGO family patents

4. Bosulif patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP15191756A	2022-04-06	SANDOZ AG	Granted and Under Opposition
EP12160638A	2015-02-16	Generics (UK) Ltd (trading as Mylan)	Opposition rejected
EP06774184A	2014-10-08	Generics [UK] Ltd (trading as Mylan)	Patent maintained as amended
EP06774184A	2014-10-07	Fresenius Kabi Deutschland GmbH	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US11103497	August, 2019	Decision	Becker Hewes

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.
US6002008	PF PRISM CV	Substituted 3-cyano quinolines	Mar, 2018 (6 years ago)
USRE42376	PF PRISM CV	Substituted 3-cyanoquinolines	Apr, 2024 (5 months ago)
US7767678	PF PRISM CV	Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same	Nov, 2026 (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).
US6002008	PF PRISM CV	Substituted 3-cyano quinolines	Mar, 2018 (6 years ago)
USRE42376 (Pediatric)	PF PRISM CV	Substituted 3-cyanoquinolines	Oct, 2024 (4 days from now)
US7417148	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Dec, 2025 (1 year, 2 months from now)
US7919625	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Dec, 2025 (1 year, 2 months from now)
US7919625 (Pediatric)	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Jun, 2026 (1 year, 8 months from now)
US7417148 (Pediatric)	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Jun, 2026 (1 year, 8 months from now)
US7767678 (Pediatric)	PF PRISM CV	Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same	May, 2027 (2 years from now)
US11103497	PF PRISM CV	Treatment of imatinib resistant leukemia	Feb, 2034 (9 years from now)
US11103497 (Pediatric)	PF PRISM CV	Treatment of imatinib resistant leukemia	Aug, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 04, 2017
Orphan Drug Exclusivity(ODE)	Sep 04, 2019
Orphan Drug Exclusivity(ODE-30)	Sep 04, 2019
New Indication(I-759)	Dec 19, 2020
Orphan Drug Exclusivity(ODE-163)	Dec 19, 2024
New Indication(I-923)	Sep 26, 2026
New Product(NP)	Sep 26, 2026
Pediatric Exclusivity(PED)	Mar 26, 2027
Orphan Drug Exclusivity(ODE-444)	Sep 26, 2030

Drugs and Companies using BOSUTINIB MONOHYDRATE ingredient

NCE-1 date: 26 March, 2026

Market Authorisation Date: 04 September, 2012

Treatment: A method of treating a neoplasm; A method of treating patients 1 year of age and older with chronic phase ph+ cml, newly-diagnosed or resistant or intolerant to prior therapy; A method for treating a ...

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 500 mg	06 Sep, 2016	2		23 Nov, 2026
400 mg	25 Oct, 2018	1		23 Nov, 2026

Strength	Dosage	Availability
EQ 400MG BASE	TABLET	Prescription
EQ 100MG BASE	TABLET	Prescription
EQ 500MG BASE	TABLET	Prescription

BOSULIF family patents

5. Camzyos patent expiration

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 (9 years from now)
USRE50050	BRISTOL	Pyrimidinedione compounds	Jun, 2034 (9 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 (9 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

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

Dosage: CAPSULE

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

CAMZYOS family patents

6. Cibinqo patent expiration

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.
US9545405	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (9 years from now)
US9035074	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (9 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).
US9549929	PFIZER	Pyrrolo[2,3-D]pyrimidine derivatives	Feb, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Feb 09, 2026
New Chemical Entity Exclusivity(NCE)	Jan 14, 2027

Drugs and Companies using ABROCITINIB ingredient

NCE-1 date: 14 January, 2026

Market Authorisation Date: 14 January, 2022

Treatment: Treatment of adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products or when use of those therapies is inadvisable

Dosage: TABLET

Strength	Dosage	Availability
200MG	TABLET	Prescription
100MG	TABLET	Prescription
50MG	TABLET	Prescription

CIBINQO family patents

7. Elucirem patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP19753296A	2021-08-02	COHAUSZ & FLORACK Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	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.
US8114863	GUERBET	Compounds comprising short aminoalcohol chains and metal complexes for medical imaging	Sep, 2028 (3 years from now)
US10973934	GUERBET	Gadolinium bearing PCTA-based contrast agents	Aug, 2039 (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).
US11590246	GUERBET	Complex of gadolinium and a chelating ligand derived from a diastereoisomerically enriched PCTA and preparation and purification process	Jan, 2040 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 21, 2027

Drugs and Companies using GADOPICLENOL ingredient

NCE-1 date: 21 September, 2026

Market Authorisation Date: 21 September, 2022

Treatment: NA

Dosage: SOLUTION

Strength	Dosage	Availability
48.51GM/100ML (485.1MG/ML)	SOLUTION	Prescription
1.4553GM/3ML (485.1MG/ML)	SOLUTION	Prescription
7.2765GM/15ML (485.1MG/ML)	SOLUTION	Prescription
4.851GM/10ML (485.1MG/ML)	SOLUTION	Prescription
14.553GM/30ML (485.1MG/ML)	SOLUTION	Prescription
3.63825GM/7.5ML (485.1MG/ML)	SOLUTION	Prescription
24.255GM/50ML (485.1MG/ML)	SOLUTION	Prescription

ELUCIREM family patents

8. Farxiga patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP08732695A	2020-12-11	Generics [UK] Limited	Granted and Under Opposition
EP08732695A	2020-12-11	Kraus & Weisert Patentanwälte PartGmbB	Granted and Under Opposition
EP08732695A	2020-12-11	Gedeon Richter Plc.	Granted and Under Opposition
EP08732695A	2020-12-11	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP08732695A	2020-12-11	Galenicum Health S.L.U.	Granted and Under Opposition
EP08732695A	2020-12-10	Zentiva, k.s.	Granted and Under Opposition
EP17203302A	2020-08-13	Generics (U.K.) Limited	Granted and Under Opposition
EP10016112A	2020-02-07	Generics (UK) Ltd	Granted and Under Opposition
EP10016112A	2020-01-21	Instone, Terry/Appleyard Lees IP LLP/Read, Howard	Granted and Under Opposition
EP15181545A	2018-09-06	Generics (U.K.) Limited	Granted and Under Opposition
EP11180259A	2015-11-25	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP11180259A	2015-11-16	PHARMATHEN S.A.	Opposition rejected
EP06801867A	2015-09-03	COOLEY LLP	Revoked
EP06801867A	2015-09-03	Generics [UK] Ltd (trading as Mylan)	Revoked
EP06801867A	2015-09-03	Teva Pharmaceutical Industries Ltd.	Revoked
EP06801867A	2015-09-02	Glaxo Group Limited	Revoked
EP06801867A	2015-09-02	PENTAFARMA, Sociedade Técnico-Medicinal, SA	Revoked
EP06801867A	2015-08-17	PHARMATHEN S.A.	Revoked
EP07784499A	2015-04-30	LEK Pharmaceuticals d.d.	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.
US6414126	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2020 (4 years ago)
US6515117	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2025 (11 months from now)
US7919598	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Dec, 2029 (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).
US6936590	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2020 (4 years ago)
US9198925	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Oct, 2020 (4 years ago)
US9238076	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 months ago)
US8461105	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2025 (6 months from now)
US8431685	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2025 (6 months from now)
US7456254	ASTRAZENECA AB	Polymer-based sustained release device	Jun, 2025 (8 months from now)
US8431685 (Pediatric)	ASTRAZENECA AB	Polymer-based sustained release device	Oct, 2025 (1 year, 4 days from now)
US8461105 (Pediatric)	ASTRAZENECA AB	Polymer-based sustained release device	Oct, 2025 (1 year, 4 days from now)
US7456254 (Pediatric)	ASTRAZENECA AB	Polymer-based sustained release device	Dec, 2025 (1 year, 2 months from now)
US6515117 (Pediatric)	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Apr, 2026 (1 year, 5 months from now)
US8329648	ASTRAZENECA AB	Methods for treating diabetes and reducing body weight	Aug, 2026 (1 year, 10 months from now)
US8906851	ASTRAZENECA AB	Method for treating diabetes	Aug, 2026 (1 year, 10 months from now)
US8906851 (Pediatric)	ASTRAZENECA AB	Method for treating diabetes	Feb, 2027 (2 years from now)
US8329648 (Pediatric)	ASTRAZENECA AB	Methods for treating diabetes and reducing body weight	Feb, 2027 (2 years from now)
US8501698	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Jun, 2027 (2 years from now)
US8501698 (Pediatric)	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Dec, 2027 (3 years from now)
US8361972	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (3 years from now)
US8716251	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (3 years from now)
US8221786	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (3 years from now)
US7851502	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Aug, 2028 (3 years from now)
US8221786 (Pediatric)	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Sep, 2028 (3 years from now)
US8716251 (Pediatric)	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Sep, 2028 (3 years from now)
US8361972 (Pediatric)	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Sep, 2028 (3 years from now)
US7851502 (Pediatric)	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Feb, 2029 (4 years from now)
US8721615	ASTRAZENECA AB	Ampoule comprising an ampoule holder	Jan, 2030 (5 years from now)
US8685934	ASTRAZENECA AB	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof	May, 2030 (5 years from now)
US7919598 (Pediatric)	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Jun, 2030 (5 years from now)
US8721615 (Pediatric)	ASTRAZENECA AB	Ampoule comprising an ampoule holder	Jul, 2030 (5 years from now)
US8685934 (Pediatric)	ASTRAZENECA AB	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof	Nov, 2030 (6 years from now)
US11826376	ASTRAZENECA AB	Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same	Jul, 2039 (14 years from now)
US11826376 (Pediatric)	ASTRAZENECA AB	Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same	Jan, 2040 (15 years from now)
US11903955	ASTRAZENECA AB	Methods of treating heart failure with reduced ejection fraction	Mar, 2040 (15 years from now)
US10973836	ASTRAZENECA AB	Methods of treating heart failure with reduced ejection fraction	Mar, 2040 (15 years from now)
US11903955 (Pediatric)	ASTRAZENECA AB	Methods of treating heart failure with reduced ejection fraction	Sep, 2040 (15 years from now)
US10973836 (Pediatric)	ASTRAZENECA AB	Methods of treating heart failure with reduced ejection fraction	Sep, 2040 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-157)	Mar 11, 2018
New Chemical Entity Exclusivity(NCE)	Jan 08, 2019
M(M-212)	Oct 20, 2020
M(M-238)	Feb 22, 2022
New Indication(I-841)	Oct 18, 2022
New Indication(I-834)	May 05, 2023
New Indication(I-857)	Apr 30, 2024
M(M-298)	May 08, 2026
New Patient Population(NPP)	Jun 12, 2027
Pediatric Exclusivity(PED)	Dec 12, 2027

Drugs and Companies using DAPAGLIFLOZIN ingredient

NCE-1 date: 12 December, 2026

Market Authorisation Date: 08 January, 2014

Treatment: Treatment of type 2 diabetes mellitus; Treatment of type 2 diabetes mellitus in combination with exenatide; Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-r...

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	08 Jan, 2018	20	22 Feb, 2022	26 May, 2030	Deferred

Strength	Dosage	Availability
5MG	TABLET	Prescription
10MG	TABLET	Prescription

FARXIGA family patents

9. Krazati patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10689377	MIRATI THERAPS	KRas G12C inhibitors	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 12, 2027
Orphan Drug Exclusivity(ODE-352)	Dec 12, 2029

Drugs and Companies using ADAGRASIB ingredient

NCE-1 date: 12 December, 2026

Market Authorisation Date: 12 December, 2022

Treatment: Treatment, in combination with cetuximab, of adult patients with kras g12c-muted locally advanced or metastatic colorectal cancer, per fda approved test, where prior treatment with fluoropyrimidine-, ...

Dosage: TABLET

Strength	Dosage	Availability
200MG	TABLET	Prescription

KRAZATI family patents

10. Lenvima patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP19151846A	2023-05-10	Welding GmbH & Co. KG	Granted and Under Opposition
EP19151846A	2023-05-10	Accord Healthcare	Granted and Under Opposition
EP19151846A	2023-05-10	STADA Arzneimittel AG	Granted and Under Opposition
EP19151846A	2023-05-10	Generics (U.K.) Limited	Granted and Under Opposition
EP19151846A	2023-05-10	Aechter, Bernd	Granted and Under Opposition
EP19151846A	2023-05-10	Maiwald GmbH	Granted and Under Opposition
EP19151846A	2023-05-09	Hansen, Norbert	Granted and Under Opposition
EP19151846A	2023-05-09	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP19151846A	2023-05-04	ELKINGTON AND FIFE LLP	Granted and Under Opposition
EP07743994A	2016-07-21	Generics [UK] Ltd (trading as Mylan)	Revoked
EP07743994A	2016-07-18	Actavis Group PTC ehf	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.
US7253286	EISAI INC	Nitrogen-containing aromatic derivatives	Oct, 2025 (1 year, 15 days from now)
US7612208	EISAI INC	Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same	Sep, 2026 (1 year, 11 months from now)
US10259791	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Aug, 2035 (10 years from now)
US10407393	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Aug, 2035 (10 years from now)
US11186547	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Aug, 2035 (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).
US7253286 (Pediatric)	EISAI INC	Nitrogen-containing aromatic derivatives	Apr, 2026 (1 year, 6 months from now)
US7612208 (Pediatric)	EISAI INC	Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same	Mar, 2027 (2 years from now)
US9006256	EISAI INC	Antitumor agent for thyroid cancer	Jul, 2027 (2 years from now)
US9006256 (Pediatric)	EISAI INC	Antitumor agent for thyroid cancer	Jan, 2028 (3 years from now)
US11090386	EISAI INC	Method for suppressing bitterness of quinoline derivative	Feb, 2036 (11 years from now)
US11186547 (Pediatric)	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Feb, 2036 (11 years from now)
US10259791 (Pediatric)	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Feb, 2036 (11 years from now)
US10407393 (Pediatric)	EISAI INC	High-purity quinoline derivative and method for manufacturing same	Feb, 2036 (11 years from now)
US11090386 (Pediatric)	EISAI INC	Method for suppressing bitterness of quinoline derivative	Aug, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-734)	May 13, 2019
New Chemical Entity Exclusivity(NCE)	Feb 13, 2020
New Indication(I-787)	Aug 15, 2021
Orphan Drug Exclusivity(ODE)	Feb 13, 2022
Orphan Drug Exclusivity(ODE-87)	Feb 13, 2022
New Indication(I-807)	Sep 17, 2022
M(M-269)	Jul 21, 2024
New Indication(I-868)	Aug 10, 2024
M(M-272)	Dec 19, 2024
Orphan Drug Exclusivity(ODE-196)	Aug 15, 2025
M(M-14)	Apr 03, 2027
Pediatric Exclusivity(PED)	Oct 03, 2027

Drugs and Companies using LENVATINIB MESYLATE ingredient

NCE-1 date: 03 October, 2026

Market Authorisation Date: 13 February, 2015

Treatment: Method for treating thyroid carcinoma including differentiated thyroid cancer; Treatment with lenvima by administering lenvima as a suspension

Dosage: CAPSULE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
4 mg and 10 mg	13 Feb, 2019	2		27 Jul, 2027

Strength	Dosage	Availability
EQ 4MG BASE	CAPSULE	Prescription
EQ 10MG BASE	CAPSULE	Prescription

LENVIMA family patents

11. Lytgobi patent expiration

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.
US9108973	TAIHO ONCOLOGY	3,5-disubstituted alkynylbenzene compound and salt thereof	Feb, 2033 (8 years from now)
US10434103	TAIHO ONCOLOGY	Crystal of 3,5-disubstituted benzene alkynyl compound	Mar, 2036 (11 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).
US11833151	TAIHO ONCOLOGY	Pharmaceutical composition including sodium alkyl sulfate	Nov, 2039 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 30, 2027
Orphan Drug Exclusivity(ODE-410)	Sep 30, 2029

Drugs and Companies using FUTIBATINIB ingredient

NCE-1 date: 30 September, 2026

Market Authorisation Date: 30 September, 2022

Treatment: Method of treating intrahepatic cholangiocarcinoma

Dosage: TABLET

Strength	Dosage	Availability
4MG	TABLET	Prescription

LYTGOBI family patents

12. Mounjaro patent expiration

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.
US9474780	ELI LILLY AND CO	GIP and GLP-1 co-agonist compounds	Jan, 2036 (11 years from now)
US11357820	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 13, 2027

Drugs and Companies using TIRZEPATIDE ingredient

NCE-1 date: 13 May, 2026

Market Authorisation Date: 28 July, 2023

Treatment: Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Dosage: SOLUTION

Strength	Dosage	Availability
2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION	Prescription
5MG/0.5ML (5MG/0.5ML)	SOLUTION	Prescription
15MG/0.5ML (15MG/0.5ML)	SOLUTION	Prescription
12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION	Prescription
10MG/0.5ML (10MG/0.5ML)	SOLUTION	Prescription
7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION	Prescription

MOUNJARO family patents

13. Mounjaro (autoinjector) patent expiration

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.
US9474780	ELI LILLY AND CO	GIP and GLP-1 co-agonist compounds	Jan, 2036 (11 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).
US8734394	ELI LILLY AND CO	Automatic injection device with delay mechanism including dual functioning biasing member	Feb, 2031 (6 years from now)
US9402957	ELI LILLY AND CO	Automatic injection device with delay mechanism including dual functioning biasing member	Jun, 2031 (6 years from now)
US11357820	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 13, 2027

Drugs and Companies using TIRZEPATIDE ingredient

NCE-1 date: 13 May, 2026

Market Authorisation Date: 28 July, 2023

Treatment: Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Dosage: SOLUTION

Strength	Dosage	Availability
7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION	Prescription
5MG/0.5ML (5MG/0.5ML)	SOLUTION	Prescription
12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION	Prescription
10MG/0.5ML (10MG/0.5ML)	SOLUTION	Prescription
15MG/0.5ML (15MG/0.5ML)	SOLUTION	Prescription
2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION	Prescription

MOUNJARO (AUTOINJECTOR) family patents

14. Nucynta patent expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7994364	January, 2016	Terminated-Denied	Gruenenthal GmbH	Rosellini Scientific, LLC

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.
US7994364	COLLEGIUM PHARM INC	Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride	Jun, 2025 (8 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).
US6071970	COLLEGIUM PHARM INC	Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases	Jun, 2017 (7 years ago)
USRE39593	COLLEGIUM PHARM INC	1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects	Aug, 2022 (2 years ago)
US7994364 (Pediatric)	COLLEGIUM PHARM INC	Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride	Dec, 2025 (1 year, 2 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 20, 2013
New Patient Population(NPP)	Jul 03, 2026
Pediatric Exclusivity(PED)	Jan 03, 2027

Drugs and Companies using TAPENTADOL HYDROCHLORIDE ingredient

NCE-1 date: 03 January, 2026

Market Authorisation Date: 20 November, 2008

Treatment: Management of moderate to severe acute pain; Relief of moderate to severe acute pain

Dosage: TABLET; SOLUTION

NUCYNTA family patents

15. Ofev patent expiration

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.
US7119093	BOEHRINGER INGELHEIM	3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate and the use thereof as a pharmaceutical composition	Feb, 2024 (7 months ago)
US6762180	BOEHRINGER INGELHEIM	Substituted indolines which inhibit receptor tyrosine kinases	Oct, 2025 (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).
US7989474	BOEHRINGER INGELHEIM	Use of Lck inhibitors for treatment of immunologic diseases	Apr, 2024 (6 months ago)
US10154990	BOEHRINGER INGELHEIM	Medicaments for the treatment or prevention of fibrotic diseases	Jan, 2026 (1 year, 2 months from now)
US6762180 (Pediatric)	BOEHRINGER INGELHEIM	Substituted indolines which inhibit receptor tyrosine kinases	Apr, 2026 (1 year, 5 months from now)
US10154990 (Pediatric)	BOEHRINGER INGELHEIM	Medicaments for the treatment or prevention of fibrotic diseases	Jul, 2026 (1 year, 8 months from now)
US10105323	BOEHRINGER INGELHEIM	Pharmaceutical dosage form for immediate release of an indolinone derivative	Jun, 2029 (4 years from now)
US9907756	BOEHRINGER INGELHEIM	Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative	Jun, 2029 (4 years from now)
US10105323 (Pediatric)	BOEHRINGER INGELHEIM	Pharmaceutical dosage form for immediate release of an indolinone derivative	Dec, 2029 (5 years from now)
US9907756 (Pediatric)	BOEHRINGER INGELHEIM	Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative	Dec, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 15, 2019
Orphan Drug Exclusivity(ODE)	Oct 15, 2021
Orphan Drug Exclusivity(ODE-77)	Oct 15, 2021
New Indication(I-805)	Sep 06, 2022
New Indication(I-825)	Mar 09, 2023
Orphan Drug Exclusivity(ODE-261)	Sep 06, 2026
Pediatric Exclusivity(PED)	Mar 06, 2027

Drugs and Companies using NINTEDANIB ESYLATE ingredient

NCE-1 date: 06 March, 2026

Market Authorisation Date: 15 October, 2014

Treatment: Treatment of idiopathic pulmonary fibrosis (ipf); Use of nintedanib for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (ssc-...

Dosage: CAPSULE

OFEV family patents

16. Omlonti patent expiration

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.
US8648097	VISIOX PHARMA	Pyridylaminoacetic acid compound	Oct, 2029 (5 years from now)
US10774072	VISIOX PHARMA	Crystal of N-substituted sulfonamide compound	Jun, 2035 (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).
US8685986	VISIOX PHARMA	Medical composition for treatment or prophylaxis of glaucoma	Oct, 2029 (5 years from now)
US10702511	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US10765750	VISIOX PHARMA	Pharmaceutical composition containing pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US11793798	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
USRE48183	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US9415038	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US10179127	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US11197849	VISIOX PHARMA	Pharmaceutical formulations comprising a pyridylaminoacetic acid compound	Jan, 2035 (10 years from now)
US11666563	VISIOX PHARMA	Pharmaceutical preparation containing pyridyl aminoacetic acid compound	Jul, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 22, 2027

Drugs and Companies using OMIDENEPAG ISOPROPYL ingredient

NCE-1 date: 22 September, 2026

Market Authorisation Date: 22 September, 2022

Treatment: Method of treating open-angle glaucoma or ocular hypertension in patients

Dosage: SOLUTION

OMLONTI family patents

17. Otezla patent expiration

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.
US6020358	AMGEN INC	Substituted phenethylsulfones and method of reducing TNFα levels	Oct, 2018 (5 years ago)
US7893101	AMGEN INC	Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof	Dec, 2023 (9 months ago)
US7427638	AMGEN INC	(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof	Feb, 2028 (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).
US9018243	AMGEN INC	Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof	Mar, 2023 (1 year, 6 months ago)
US6962940	AMGEN INC	(+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof	Mar, 2023 (1 year, 6 months ago)
US8455536	AMGEN INC	Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione	Mar, 2023 (1 year, 6 months ago)
US9724330	AMGEN INC	Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione	Mar, 2023 (1 year, 6 months ago)
US7659302	AMGEN INC	Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione	Mar, 2023 (1 year, 6 months ago)
US8802717	AMGEN INC	Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione	Mar, 2023 (1 year, 6 months ago)
US7208516	AMGEN INC	Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione	Mar, 2023 (1 year, 6 months ago)
US7427638 (Pediatric)	AMGEN INC	(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof	Aug, 2028 (3 years from now)
US10092541	AMGEN INC	Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast	May, 2034 (9 years from now)
US9872854	AMGEN INC	Methods for the treatment of psoriatic arthritis using apremilast	May, 2034 (9 years from now)
US10092541 (Pediatric)	AMGEN INC	Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast	Nov, 2034 (10 years from now)
US9872854 (Pediatric)	AMGEN INC	Methods for the treatment of psoriatic arthritis using apremilast	Nov, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-694)	Sep 23, 2017
New Chemical Entity Exclusivity(NCE)	Mar 21, 2019
New Indication(I-803)	Jul 19, 2022
M(M-257)	Apr 10, 2023
New Indication(I-884)	Dec 20, 2024
Orphan Drug Exclusivity(ODE-248)	Jul 19, 2026
M(M-299)	Jul 20, 2026
Pediatric Exclusivity(PED)	Jan 20, 2027
New Patient Population(NPP)	Apr 25, 2027

Drugs and Companies using APREMILAST ingredient

NCE-1 date: 20 January, 2026

Market Authorisation Date: 21 March, 2014

Treatment: Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy; Use of otezla (apremilast) for the treatment of psoriatic arthritis; Treatment of adult patients wi...

Dosage: TABLET

OTEZLA family patents

18. Pluvicto patent expiration

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.
US10406240	NOVARTIS	PSMA binding ligand-linker conjugates and methods for using	Aug, 2028 (3 years from now)
US11318121	NOVARTIS	PSMA binding ligand-linker conjugates and methods for using	Aug, 2028 (3 years from now)
US10398791	NOVARTIS	Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer	Oct, 2034 (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).
US11951190	NOVARTIS	Use of labeled inhibitors of prostate specific membrane antigen (PSMA), as agents for the treatment of prostate cancer	Nov, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Mar 23, 2027

Drugs and Companies using LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN ingredient

NCE-1 date: 23 March, 2026

Market Authorisation Date: 23 March, 2022

Treatment: For treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathwa...

Dosage: SOLUTION

PLUVICTO family patents

19. Pomalyst patent expiration

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.
US8828427	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	Jun, 2031 (6 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).
US5635517	BRISTOL	Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines	Jul, 2016 (8 years ago)
US6476052	BRISTOL	Isoindolines, method of use, and pharmaceutical compositions	Jul, 2016 (8 years ago)
US5653517	BRISTOL	Process and system for determination of friction/slip characteristics of road vehicle tires	Jul, 2016 (8 years ago)
US8158653	BRISTOL	Pharmaceutical compositions of 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-amino isoindoline	Aug, 2016 (8 years ago)
US6316471	BRISTOL	Isoindolines, method of use, and pharmaceutical compositions	Aug, 2016 (8 years ago)
US8589188	BRISTOL	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (6 years ago)
US8204763	BRISTOL	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (6 years ago)
US6561976	BRISTOL	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (6 years ago)
US6045501	BRISTOL	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (6 years ago)
US6908432	BRISTOL	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (6 years ago)
US8315886	BRISTOL	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated	Oct, 2020 (3 years ago)
US6561977	BRISTOL	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated	Oct, 2020 (3 years ago)
US8626531	BRISTOL	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated	Oct, 2020 (3 years ago)
US6755784	BRISTOL	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated	Oct, 2020 (3 years ago)
US6315720	BRISTOL	Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug	Oct, 2020 (3 years ago)
US8735428	BRISTOL	Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	May, 2023 (1 year, 4 months ago)
US8673939	BRISTOL	Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	May, 2023 (1 year, 4 months ago)
US8735428 (Pediatric)	BRISTOL	Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	Nov, 2023 (10 months ago)
US8673939 (Pediatric)	BRISTOL	Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	Nov, 2023 (10 months ago)
US8198262	BRISTOL	Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	Jun, 2025 (8 months from now)
US8198262 (Pediatric)	BRISTOL	Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione	Dec, 2025 (1 year, 2 months from now)
US9993467	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	May, 2030 (5 years from now)
US10555939	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	May, 2030 (5 years from now)
US10555939 (Pediatric)	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	Nov, 2030 (6 years from now)
US9993467 (Pediatric)	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	Nov, 2030 (6 years from now)
US8828427 (Pediatric)	BRISTOL	Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione	Dec, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 08, 2018
New Indication(I-707)	Apr 23, 2018
Orphan Drug Exclusivity(ODE)	Feb 08, 2020
Orphan Drug Exclusivity(ODE-43)	Feb 08, 2020
M(M-14)	Nov 20, 2023
Orphan Drug Exclusivity(ODE-296)	May 14, 2027
Orphan Drug Exclusivity(ODE-297)	May 14, 2027
Pediatric Exclusivity(PED)	Nov 14, 2027

Drugs and Companies using POMALIDOMIDE ingredient

NCE-1 date: 14 November, 2026

Market Authorisation Date: 08 February, 2013

Treatment: Use of pomalidomide to inhibit the secretion of pro-inflammation cytokines, including tumor necrosis factor alpha; Use of pomalidomide for the treatment of multiple myeloma; Use of pomalidomide while ...

Dosage: CAPSULE

POMALYST family patents

20. Pyrukynd patent expiration

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.
USRE49582	AGIOS PHARMS INC	Therapeutic compounds and compositions	Feb, 2031 (6 years from now)
US8785450	AGIOS PHARMS INC	Therapeutic compounds and compositions	Feb, 2031 (6 years from now)
US11254652	AGIOS PHARMS INC	Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide	Nov, 2038 (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).
US9682080	AGIOS PHARMS INC	Pyruvate kinase activators for use in therapy	May, 2032 (7 years from now)
US9980961	AGIOS PHARMS INC	Pyruvate kinase activators for use in therapy	May, 2032 (7 years from now)
US10632114	AGIOS PHARMS INC	Pyruvate kinase activators for use in therapy	May, 2032 (7 years from now)
US9193701	AGIOS PHARMS INC	Pyruvate kinase activators for use in therapy	Oct, 2032 (8 years from now)
US11793806	AGIOS PHARMS INC	Pyruvate kinase activators for use in therapy	Apr, 2033 (8 years from now)
US11234976	AGIOS PHARMS INC	Methods of using pyruvate kinase activators	Oct, 2038 (14 years from now)
US11878049	AGIOS PHARMS INC	Mitapivat therapy and modulators of cytochrome P450	Jul, 2041 (16 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 17, 2027
Orphan Drug Exclusivity(ODE-392)	Feb 17, 2029

Drugs and Companies using MITAPIVAT SULFATE ingredient

NCE-1 date: 17 February, 2026

Market Authorisation Date: 17 February, 2022

Treatment: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (pk) deficiency; Method for increasing the lifetime of red blood cells (rbcs) for the t...

Dosage: TABLET

PYRUKYND family patents

21. Quviviq patent expiration

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.
US9732075	IDORSIA	Benzimidazole-proline derivatives	Jun, 2033 (8 years from now)
US9790208	IDORSIA	Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist	Dec, 2034 (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).
US10023560	IDORSIA	Crystalline salt form of (S)-(2-(6 chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist	Dec, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 07, 2027

Drugs and Companies using DARIDOREXANT HYDROCHLORIDE ingredient

NCE-1 date: 07 April, 2026

Market Authorisation Date: 07 April, 2022

Treatment: Treatment of insomnia

Dosage: TABLET

QUVIVIQ family patents

22. Relyvrio patent expiration

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).
US11071742	AMYLYX	Compositions for improving cell viability and methods of use thereof	Dec, 2033 (9 years from now)
US10251896	AMYLYX	Compositions for improving cell viability and methods of use thereof	Dec, 2033 (9 years from now)
US10857162	AMYLYX	Compositions for improving cell viability and methods of use thereof	Dec, 2033 (9 years from now)
US9872865	AMYLYX	Compositions for improving cell viability and methods of use thereof	Dec, 2033 (9 years from now)
US11583542	AMYLYX	Compositions of bile acids and phenylbutyrate compounds	Jul, 2040 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 29, 2027
Orphan Drug Exclusivity(ODE-411)	Sep 29, 2029

Drugs and Companies using SODIUM PHENYLBUTYRATE; TAURURSODIOL ingredient

NCE-1 date: 29 September, 2026

Market Authorisation Date: 29 September, 2022

Treatment: Treatment of amyotrophic lateral sclerosis (als) in adults

Dosage: FOR SUSPENSION

RELYVRIO family patents

23. Rezlidhia patent expiration

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.
US9834539	RIGEL PHARMS	Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors	Sep, 2035 (10 years from now)
US10532047	RIGEL PHARMS	Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile	May, 2039 (14 years from now)
US12053463	RIGEL PHARMS	Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile	May, 2039 (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).
US10414752	RIGEL PHARMS	Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors	Sep, 2035 (10 years from now)
US11498913	RIGEL PHARMS	Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors	Sep, 2035 (10 years from now)
US10550098	RIGEL PHARMS	Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors	Sep, 2035 (10 years from now)
US11013733	RIGEL PHARMS	Inhibiting mutant isocitrate dehydrogenase 1 (mlDH-1)	May, 2039 (14 years from now)
US11376246	RIGEL PHARMS	Inhibiting mutant IDH-1	May, 2039 (14 years from now)
US11497743	RIGEL PHARMS	Treating patients harboring an isocitrate dehydrogenase 1 (IDH-1) mutation	May, 2039 (14 years from now)
US10959994	RIGEL PHARMS	Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile	May, 2039 (14 years from now)
US11013734	RIGEL PHARMS	Treating patients harboring an isocitrate dehydrogenase-1 (IDH-1) mutation	May, 2039 (14 years from now)
US11738018	RIGEL PHARMS	Inhibiting mutant isocitrate dehydrogenase 1 (mIDH-1)	Jul, 2039 (14 years from now)
US11723905	RIGEL PHARMS	Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile	Nov, 2039 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 01, 2027
Orphan Drug Exclusivity(ODE-413)	Dec 01, 2029

Drugs and Companies using OLUTASIDENIB ingredient

NCE-1 date: 01 December, 2026

Market Authorisation Date: 01 December, 2022

Treatment: A method of treating a cancer characterized by an idh1 mutation where the cancer is acute myeloid leukemia (aml); A method of treating acute myeloid leukemia (aml) in patients with an isocitrate dehyd...

Dosage: CAPSULE

REZLIDHIA family patents

24. Solosec patent expiration

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).
US10682338	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US11324721	LUPIN	Secnidazole for use in the treatment of trichomoniasis	Sep, 2035 (10 years from now)
US10335390	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US10849884	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US10857133	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US11000508	LUPIN	Secnidazole for use in the treatment of trichomoniasis	Sep, 2035 (10 years from now)
US11000507	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US11020377	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)
US11602522	LUPIN	Secnidazole for use in the treatment of sexually transmitted infection	Sep, 2035 (10 years from now)
US11684607	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 15, 2022
New Indication(I-866)	Jun 30, 2024
New Patient Population(NPP)	Jan 26, 2025
Generating Antibiotic Incentives Now(GAIN)	Sep 15, 2027

Drugs and Companies using SECNIDAZOLE ingredient

NCE-1 date: 15 September, 2026

Market Authorisation Date: 15 September, 2017

Treatment: Treatment of bacterial vaginosis in adult women; Treatment of trichomoniasis in patients 12 years of age and older; Treatment of bacterial vaginosis in female patients 12 years of age and older

Dosage: GRANULE

SOLOSEC family patents

25. Sotyktu patent expiration

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.
US10000480	BRISTOL	Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses	Nov, 2033 (9 years from now)
USRE47929	BRISTOL	Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFNα responses	Nov, 2033 (9 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).
US11021475	BRISTOL	Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses	Nov, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 09, 2027

Drugs and Companies using DEUCRAVACITINIB ingredient

NCE-1 date: 09 September, 2026

Market Authorisation Date: 09 September, 2022

Treatment: Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Dosage: TABLET

SOTYKTU family patents

26. Sunlenca patent expiration

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.
US9951043	GILEAD SCIENCES INC	Therapeutic compounds	Feb, 2034 (9 years from now)
US10071985	GILEAD SCIENCES INC	Therapeutic compounds	Aug, 2037 (12 years from now)
US11267799	GILEAD SCIENCES INC	Solid forms of an HIV capsid inhibitor	Aug, 2038 (13 years from now)
US11944611	GILEAD SCIENCES INC	Capsid inhibitors for the treatment of HIV	Jun, 2041 (16 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).
US10654827	GILEAD SCIENCES INC	Therapeutic compounds	Aug, 2037 (12 years from now)
US11944611	GILEAD SCIENCES INC	Capsid inhibitors for the treatment of HIV	Jun, 2041 (16 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 22, 2027

Drugs and Companies using LENACAPAVIR SODIUM ingredient

NCE-1 date: 22 December, 2026

Market Authorisation Date: 22 December, 2022

Treatment: In combination with other antiretroviral(s), for the treatment of hiv-1 infection in heavily-treatment experienced adults with multidrug resistant hiv-1 infection

Dosage: SOLUTION; TABLET

SUNLENCA family patents

27. Terlivaz patent expiration

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).
US10335452	MALLINCKRODT IRELAND	Method of treating patients with hepatorenal syndrome type 1	Apr, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 14, 2027
Orphan Drug Exclusivity(ODE-406)	Sep 14, 2029

Drugs and Companies using TERLIPRESSIN ACETATE ingredient

NCE-1 date: 14 September, 2026

Market Authorisation Date: 14 September, 2022

Treatment: A method to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function

Dosage: POWDER

TERLIVAZ family patents

28. Trintellix patent expiration

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.
US7144884	TAKEDA PHARMS USA	Phenyl-piperazine derivatives as serotonin reuptake inhibitors	Jun, 2026 (1 year, 8 months from now)
US8722684	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2031 (6 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).
US8476279	TAKEDA PHARMS USA	Phenyl-piperazine derivatives as serotonin reuptake inhibitors	Oct, 2022 (2 years ago)
US7144884 (Pediatric)	TAKEDA PHARMS USA	Phenyl-piperazine derivatives as serotonin reuptake inhibitors	Dec, 2026 (2 years from now)
US9125910	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US9125909	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US9125908	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US9227946	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US8969355	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US9861630	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US11458134	TAKEDA PHARMS USA	1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Jun, 2027 (2 years from now)
US11458134 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US9125910 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US9125908 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US9125909 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US9861630 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US8969355 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US9227946 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment	Dec, 2027 (3 years from now)
US8722684 (Pediatric)	TAKEDA PHARMS USA	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment	Dec, 2031 (7 years from now)
US9278096	TAKEDA PHARMS USA	Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity	Mar, 2032 (7 years from now)
US9278096 (Pediatric)	TAKEDA PHARMS USA	Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity	Sep, 2032 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 30, 2018
M(M-227)	May 02, 2021
M(M-234)	Oct 19, 2021
M(M-267)	Nov 13, 2023
M(M-187)	Jan 22, 2024
M(M-232)	Aug 23, 2026
Pediatric Exclusivity(PED)	Feb 23, 2027

Drugs and Companies using VORTIOXETINE HYDROBROMIDE ingredient

NCE-1 date: 23 February, 2026

Market Authorisation Date: 30 September, 2013

Treatment: Method of treating an affective disorder such as depression; Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function; Method of treating depressi...

Dosage: TABLET

TRINTELLIX family patents

29. Vabomere patent expiration

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.
US8680136	REMPEX	Cyclic boronic acid ester derivatives and therapeutic uses thereof	Aug, 2031 (6 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).
US10183034	REMPEX	Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives	Aug, 2031 (6 years from now)
US10561675	REMPEX	Cyclic boronic acid ester derivatives and therapeutic uses thereof	Aug, 2031 (6 years from now)
US11007206	REMPEX	Cyclic boronic acid ester derivatives and therapeutic uses thereof	Aug, 2031 (6 years from now)
US9694025	REMPEX	Cyclic boronic acid ester derivatives and therapeutic uses thereof	Aug, 2031 (6 years from now)
US10172874	REMPEX	Pharmaceutical compositions comprising cyclic boronic acid ester derivatives	Aug, 2031 (6 years from now)
US11376237	REMPEX	Methods of treating bacterial infections	Apr, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 29, 2022
Generating Antibiotic Incentives Now(GAIN)	Aug 29, 2027

Drugs and Companies using MEROPENEM; VABORBACTAM ingredient

NCE-1 date: 29 August, 2026

Market Authorisation Date: 29 August, 2017

Treatment: Treatment of complicated urinary tract infection (cuti) including pyelonephritis caused by the following susceptible microorganisms: escherichia coli, klebsiella pneumonia, and enterobacter cloacae sp...

Dosage: POWDER

VABOMERE family patents

30. Veklury patent expiration

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.
USRE46762	GILEAD SCIENCES INC	1′-substituted carba-nucleoside analogs for antiviral treatment	Apr, 2029 (4 years from now)
US8318682	GILEAD SCIENCES INC	1′substituted carba-nucleoside analogs for antiviral treatment	Apr, 2029 (4 years from now)
US8008264	GILEAD SCIENCES INC	1′-substituted carba-nucleoside analogs for antiviral treatment	Sep, 2029 (4 years from now)
US10065958	GILEAD SCIENCES INC	Methods and compounds for treating Paramyxoviridae virus infections	Sep, 2031 (6 years from now)
US11492353	GILEAD SCIENCES INC	Methods and compounds for treating Paramyxoviridae virus infections	Dec, 2031 (7 years from now)
US9724360	GILEAD SCIENCES INC	Methods for treating Filoviridae virus infections	Oct, 2035 (11 years from now)
US9949994	GILEAD SCIENCES INC	Methods for treating Filoviridae virus infections	Oct, 2035 (11 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).
US8318682 (Pediatric)	GILEAD SCIENCES INC	1′substituted carba-nucleoside analogs for antiviral treatment	Oct, 2029 (5 years from now)
USRE46762 (Pediatric)	GILEAD SCIENCES INC	1′-substituted carba-nucleoside analogs for antiviral treatment	Oct, 2029 (5 years from now)
US8008264 (Pediatric)	GILEAD SCIENCES INC	1′-substituted carba-nucleoside analogs for antiviral treatment	Mar, 2030 (5 years from now)
US10065958 (Pediatric)	GILEAD SCIENCES INC	Methods and compounds for treating Paramyxoviridae virus infections	Mar, 2032 (7 years from now)
US11492353 (Pediatric)	GILEAD SCIENCES INC	Methods and compounds for treating Paramyxoviridae virus infections	Jun, 2032 (7 years from now)
US9724360 (Pediatric)	GILEAD SCIENCES INC	Methods for treating Filoviridae virus infections	Apr, 2036 (11 years from now)
US9949994 (Pediatric)	GILEAD SCIENCES INC	Methods for treating Filoviridae virus infections	Apr, 2036 (11 years from now)
US11382926	GILEAD SCIENCES INC	Methods for treating Arenaviridae and Coronaviridae virus infections	Sep, 2036 (11 years from now)
US10695361	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Sep, 2036 (11 years from now)
US11007208	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Sep, 2036 (11 years from now)
US11007208 (Pediatric)	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Mar, 2037 (12 years from now)
US11382926 (Pediatric)	GILEAD SCIENCES INC	Methods for treating Arenaviridae and Coronaviridae virus infections	Mar, 2037 (12 years from now)
US10695361 (Pediatric)	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Mar, 2037 (12 years from now)
US11266681	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jul, 2038 (13 years from now)
US10675296	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jul, 2038 (13 years from now)
US11975017	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jul, 2038 (13 years from now)
US11266681 (Pediatric)	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jan, 2039 (14 years from now)
US11975017 (Pediatric)	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jan, 2039 (14 years from now)
US10675296 (Pediatric)	GILEAD SCIENCES INC	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections	Jan, 2039 (14 years from now)
US11491169	GILEAD SCIENCES INC	Remdesivir treatment methods	May, 2041 (16 years from now)
US11903953	GILEAD SCIENCES INC	Remdesivir treatment methods	May, 2041 (16 years from now)
US11975012	GILEAD SCIENCES INC	Remdesivir treatment methods	May, 2041 (16 years from now)
US11491169 (Pediatric)	GILEAD SCIENCES INC	Remdesivir treatment methods	Nov, 2041 (17 years from now)
US11903953 (Pediatric)	GILEAD SCIENCES INC	Remdesivir treatment methods	Nov, 2041 (17 years from now)
US11975012 (Pediatric)	GILEAD SCIENCES INC	Remdesivir treatment methods	Nov, 2041 (17 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosing Schedule(D-183)	Jan 21, 2025
New Patient Population(NPP)	Apr 25, 2025
New Chemical Entity Exclusivity(NCE)	Oct 22, 2025
M(M-301)	Jul 13, 2026
Pediatric Exclusivity(PED)	Jan 13, 2027

Drugs and Companies using REMDESIVIR ingredient

NCE-1 date: 13 January, 2026

Market Authorisation Date: 22 October, 2020

Treatment: Treatment of coronavirus disease 2019 (covid-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization; Treatment of coronavirus disease 2019 (covid-19) in non-hospitali...

Dosage: POWDER; SOLUTION

VEKLURY family patents

31. Vonjo patent expiration

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.
US8153632	CTI BIOPHARMA CORP	Oxygen linked pyrimidine derivatives	Jan, 2029 (4 years from now)
US8980873	CTI BIOPHARMA CORP	11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene citrate salt	Mar, 2030 (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).
US9573964	CTI BIOPHARMA CORP	Oxygen linked pyrimidine derivatives	May, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 28, 2027
Orphan Drug Exclusivity(ODE-397)	Feb 28, 2029

Drugs and Companies using PACRITINIB CITRATE ingredient

NCE-1 date: 28 February, 2026

Market Authorisation Date: 28 February, 2022

Treatment: Treatment of myelofibrosis with pacritinib; Use of pacritinib for inhibiting janus associated kinase 2(jak2)

Dosage: CAPSULE

VONJO family patents

32. Voquezna patent expiration

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.
US7977488	PHATHOM	1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors	Aug, 2028 (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).
US9186411	PHATHOM	Pharmaceutical composition	Aug, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 01, 2026
New Chemical Entity Exclusivity(NCE)	May 03, 2027
New Indication(I-948)	Jul 17, 2027

Drugs and Companies using VONOPRAZAN FUMARATE ingredient

NCE-1 date: 03 May, 2026

Market Authorisation Date: 01 November, 2023

Treatment: NA

Dosage: TABLET

VOQUEZNA family patents

33. Vtama patent expiration

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.
US10647649	DERMAVANT SCI	Process for preparing tapinarof	Nov, 2038 (14 years from now)
US11597692	DERMAVANT SCI	Process for preparing tapinarof	Nov, 2038 (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).
US11458108	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US10426743	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US11612573	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US11622945	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US10195160	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US11617724	DERMAVANT SCI	Topical pharmaceutical compositions	May, 2036 (11 years from now)
US11590088	DERMAVANT SCI	Use of Tapinarof for the treatment of chronic plaque psoriasis	Nov, 2039 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 23, 2027

Drugs and Companies using TAPINAROF ingredient

NCE-1 date: 23 May, 2026

Market Authorisation Date: 23 May, 2022

Treatment: Topical treatment of plaque psoriasis in adults

Dosage: CREAM

VTAMA family patents

34. Xenoview patent expiration

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).
US10583205	POLAREAN	Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices	Feb, 2035 (10 years from now)
US11052161	POLAREAN	Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices	Dec, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 23, 2027

Drugs and Companies using XENON XE-129 HYPERPOLARIZED ingredient

NCE-1 date: 23 December, 2026

Market Authorisation Date: 23 December, 2022

Treatment: NA

Dosage: GAS

XENOVIEW family patents

35. Xigduo Xr patent expiration

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.
US6414126	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2020 (4 years ago)
US6515117	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2025 (11 months from now)
US7919598	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Dec, 2029 (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).
US6936590	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2020 (4 years ago)
US9198925	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Oct, 2020 (4 years ago)
US6515117 (Pediatric)	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Apr, 2026 (1 year, 5 months from now)
US8501698	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Jun, 2027 (2 years from now)
US8501698 (Pediatric)	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Dec, 2027 (3 years from now)
US8685934	ASTRAZENECA AB	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof	May, 2030 (5 years from now)
US7919598 (Pediatric)	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Jun, 2030 (5 years from now)
US9616028	ASTRAZENECA AB	Bilayer tablet formulations	Nov, 2030 (6 years from now)
US8685934 (Pediatric)	ASTRAZENECA AB	Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof	Nov, 2030 (6 years from now)
US9616028 (Pediatric)	ASTRAZENECA AB	Bilayer tablet formulations	May, 2031 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 08, 2019
M(M-238)	Feb 22, 2022
New Indication(I-841)	Oct 18, 2022
New Patient Population(NPP)	Jun 12, 2027
Pediatric Exclusivity(PED)	Dec 12, 2027

Drugs and Companies using DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ingredient

NCE-1 date: 12 December, 2026

Market Authorisation Date: 28 July, 2017

Treatment: Treatment of type 2 diabetes mellitus; Treatment of type 2 diabetes mellitus in a patient, wherein glycemic control (hba1c < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazo...

Dosage: TABLET, EXTENDED RELEASE

XIGDUO XR family patents

36. Zepbound patent expiration

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.
US9474780	ELI LILLY AND CO	GIP and GLP-1 co-agonist compounds	Jan, 2036 (11 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).
US11357820	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)
US11918623	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 13, 2027

Drugs and Companies using TIRZEPATIDE ingredient

NCE-1 date: 13 May, 2026

Market Authorisation Date: 28 March, 2024

Treatment: For chronic weight management in adults with an initial body mass index (bmi) of: 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related como...

Dosage: SOLUTION

ZEPBOUND family patents

37. Zepbound (autoinjector) patent expiration

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.
US9474780	ELI LILLY AND CO	GIP and GLP-1 co-agonist compounds	Jan, 2036 (11 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).
US8734394	ELI LILLY AND CO	Automatic injection device with delay mechanism including dual functioning biasing member	Feb, 2031 (6 years from now)
US9402957	ELI LILLY AND CO	Automatic injection device with delay mechanism including dual functioning biasing member	Jun, 2031 (6 years from now)
US11918623	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)
US11357820	ELI LILLY AND CO	GIP/GLP1 agonist compositions	Jun, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 08, 2026
New Chemical Entity Exclusivity(NCE)	May 13, 2027

Drugs and Companies using TIRZEPATIDE ingredient

NCE-1 date: 13 May, 2026

Market Authorisation Date: 28 March, 2024

Dosage: SOLUTION

ZEPBOUND (AUTOINJECTOR) family patents

38. Ztalmy patent expiration

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).
US8318714	MARINUS	Liquid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US7858609	MARINUS	Solid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US8367651	MARINUS	Solid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US8618087	MARINUS	Solid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US8022054	MARINUS	Liquid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US9029355	MARINUS	Solid ganaxolone compositions and methods for the making and use thereof	Nov, 2026 (2 years from now)
US9056116	MARINUS	Liquid ganaxolone formulations and methods for the making and use thereof	Nov, 2026 (2 years from now)
US10603308	MARINUS	Methods and compositions for treatment of epileptic disorders	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 01, 2027
Orphan Drug Exclusivity(ODE-395)	Jun 01, 2029

Drugs and Companies using GANAXOLONE ingredient

NCE-1 date: 01 June, 2026

Market Authorisation Date: 01 June, 2022

Treatment: Treatment of seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 years of age and older

Dosage: SUSPENSION

Application	Filing Date	Opposition Party	Legal Status

EP10162667A	2020-03-02	Galenicum Health S.L.U.	Revoked
EP10162667A	2020-02-28	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Revoked
EP10162667A	2020-02-28	Zentiva k.s.	Revoked
EP10162667A	2020-02-28	Hexal AG	Revoked
EP10162667A	2020-02-26	Wuesthoff & Wuesthoff Patentanwälte PartG mbB	Revoked
EP15177140A	2019-10-16	KRKA, d.d., Novo mesto	Granted and Under Opposition
EP15177140A	2019-10-16	Galenicum Health S.L.U.	Granted and Under Opposition
EP15177140A	2019-10-16	Zentiva k.s.	Granted and Under Opposition
EP15177140A	2019-10-16	Cipla Ltd	Granted and Under Opposition
EP15177140A	2019-10-16	STADA Arzneimittel AG	Granted and Under Opposition
EP15177140A	2019-10-16	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP15177140A	2019-10-16	Dr. Reddy's Laboratories Limited	Granted and Under Opposition
EP15177140A	2019-10-15	Hexal AG	Granted and Under Opposition
EP15177140A	2019-10-15	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP15177140A	2019-10-15	Química Sintética, S.A.	Granted and Under Opposition
EP15177140A	2019-10-11	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP15177140A	2019-10-11	Generics (UK) Ltd	Granted and Under Opposition
EP15177140A	2019-10-10	Accord Healthcare Ltd	Granted and Under Opposition
EP15177140A	2019-10-10	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Granted and Under Opposition
EP15177140A	2019-10-03	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10162653A	2018-02-14	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Revoked
EP09003138A	2017-07-31	Accord Healthcare	Revoked
EP03721414A	2010-05-26	Ratiopharm GmbH	Revoked

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg, 75 mg, and 100 mg	20 Nov, 2012	4		27 Jun, 2025
20 mg/mL	20 Dec, 2013	1		27 Jun, 2025

Strength	Dosage	Availability
EQ 75MG BASE	TABLET	Prescription
EQ 50MG BASE	TABLET	Prescription
EQ 100MG BASE	TABLET	Prescription
EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	Discontinued

Application	Filing Date	Opposition Party	Legal Status

EP09757601A	2019-08-20	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09757601A	2019-08-20	Generics (U.K.) Limited	Granted and Under Opposition
EP09757601A	2019-08-20	Ter Meer Steinmeister & Partner Patentanwälte mbB	Granted and Under Opposition
EP09757593A	2018-11-21	Zentiva Group, a.s.	Granted and Under Opposition
EP09757593A	2018-11-21	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09757593A	2018-11-21	Generics (U.K.) Limited	Granted and Under Opposition
EP09757593A	2018-11-21	Galenicum Health S.L.	Granted and Under Opposition
EP05823930A	2013-08-07	SANDOZ AG	Opposition rejected

Strength	Dosage	Availability
EQ 150MG BASE	CAPSULE	Prescription
EQ 100MG BASE	CAPSULE	Prescription

Strength	Dosage	Availability
30MG	TABLET	Prescription
10MG	TABLET	Prescription
20MG	TABLET	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP08798020A	2020-07-07	Orano Med	Revoked
EP08798020A	2020-07-07	Boult Wade Tennant LLP	Revoked

Application	Filing Date	Opposition Party	Legal Status

EP18160247A	2020-01-10	Hoffmann Eitle	Granted and Under Opposition
EP18160247A	2020-01-09	Generics (UK) Ltd	Granted and Under Opposition
EP18160247A	2020-01-08	HGF Limited	Granted and Under Opposition
EP18160247A	2019-12-16	Pruß, Timo	Granted and Under Opposition
EP15199540A	2019-08-07	Generics (UK) Ltd	Revoked
EP15199521A	2019-08-07	Hamm&Wittkopp Patentanwälte PartmbB	Revoked
EP15199521A	2019-08-07	Bachelin, Martin, Dr.	Revoked
EP15199521A	2019-08-07	Generics [UK] Ltd	Revoked
EP15199526A	2019-08-07	Generics [UK] Ltd	Revoked
EP15199521A	2019-07-25	Pruß, Timo	Revoked
EP15199521A	2019-07-25	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Revoked
EP10720107A	2017-10-18	Hoffmann Eitle	Revoked
EP10720107A	2017-10-18	STADA Arzneimittel AG	Revoked
EP10720107A	2017-10-17	HGF Limited	Revoked
EP10720107A	2017-10-17	Generics [UK] Ltd	Revoked
EP10720107A	2017-10-12	Teva Pharmaceutical Industries Ltd	Revoked
EP09008756A	2015-07-22	Accord Healthcare Ltd	Revoked
EP09008756A	2015-07-21	Generics [UK] Limited (trading as Mylan)	Revoked
EP09008756A	2015-07-21	Hexal AG	Revoked
EP09008756A	2015-07-20	Intellectual Property Services	Revoked
EP09008756A	2015-07-17	Synthon B.V.	Revoked
EP09008756A	2015-07-14	Actavis Group PTC EHF	Revoked
EP04783095A	2012-08-02	Teva Pharmaceutical Industries Ltd.	Revoked
EP04783095A	2012-08-01	Generics [UK] Limited	Revoked
EP03728969A	2010-12-01	STRAWMAN LIMITED	Revoked
EP03728969A	2010-11-30	Synthon B.V.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6045501	April, 2015	Final Written Decision	Celgene Corporation	Coalition For Affordable Drugs VI LLC
US6315720	April, 2015	FWD Entered	Celgene Corporation	Coalition for Affordable Drugs VI LLC
US5635517	May, 2015	Terminated-Denied	Celgene Corporation	Coalition for Affordable Drugs VI LLC

Strength	Dosage	Availability
EQ 20MG BASE	TABLET	Prescription
EQ 50MG BASE	TABLET	Prescription
EQ 5MG BASE	TABLET	Prescription

Strength	Dosage	Availability
EQ 25MG BASE	TABLET	Prescription
EQ 50MG BASE	TABLET	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP14775675A	2021-01-12	Lederer & Keller Patentanwälte Partnerschaft mbB	Opposition rejected
EP14775675A	2021-01-11	Bruschettini S.r.l.	Opposition rejected

Strength	Dosage	Availability
EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION	Prescription
EQ 300MG BASE	TABLET	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP07764495A	2012-10-11	Sandoz AG	Patent maintained as amended
EP08850935A	2012-09-21	SANDOZ AG	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10561675	November, 2016	Decision	Rempex Pharmaceuticals, Inc.

Strength	Dosage	Availability
100MG/VIAL	POWDER	Prescription
100MG/20ML (5MG/ML)	SOLUTION	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US11590088	April, 2024	Pending	Dermavant Sciences GmbH et al.	Encube Ethicals Pvt. Ltd.

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg/1000 mg	29 Oct, 2018	1		16 Dec, 2029
5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	08 Jan, 2018	10		26 May, 2030

Strength	Dosage	Availability
10MG;1GM	TABLET, EXTENDED RELEASE	Prescription
2.5MG;1GM	TABLET, EXTENDED RELEASE	Prescription
5MG;1GM	TABLET, EXTENDED RELEASE	Prescription
10MG;500MG	TABLET, EXTENDED RELEASE	Prescription
5MG;500MG	TABLET, EXTENDED RELEASE	Prescription

Pharsight

Pharsight

Drugs facing NCE-1 in 2026

1. Amvuttra patent expiration

AMVUTTRA family patents

2. Baxdela patent expiration

BAXDELA 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. Bludigo patent expiration

BLUDIGO family patents

4. Bosulif patent expiration

BOSULIF family patents

5. Camzyos patent expiration

CAMZYOS family patents

6. Cibinqo patent expiration

CIBINQO family patents

7. Elucirem patent expiration

ELUCIREM family patents

8. Farxiga patent expiration

FARXIGA family patents

9. Krazati patent expiration

KRAZATI family patents

10. Lenvima patent expiration

LENVIMA family patents

11. Lytgobi patent expiration

LYTGOBI family patents

12. Mounjaro patent expiration

MOUNJARO family patents

13. Mounjaro (autoinjector) patent expiration

MOUNJARO (AUTOINJECTOR) family patents

14. Nucynta patent expiration

NUCYNTA family patents

15. Ofev patent expiration

OFEV family patents

16. Omlonti patent expiration

OMLONTI family patents

17. Otezla patent expiration

OTEZLA family patents

18. Pluvicto patent expiration

PLUVICTO family patents

19. Pomalyst patent expiration

POMALYST family patents

20. Pyrukynd patent expiration

PYRUKYND family patents

21. Quviviq patent expiration

QUVIVIQ family patents

22. Relyvrio patent expiration

RELYVRIO family patents

23. Rezlidhia patent expiration

REZLIDHIA family patents

24. Solosec patent expiration

SOLOSEC family patents

25. Sotyktu patent expiration

SOTYKTU family patents

26. Sunlenca patent expiration

SUNLENCA family patents

27. Terlivaz patent expiration

TERLIVAZ family patents

28. Trintellix patent expiration

TRINTELLIX family patents

29. Vabomere patent expiration

VABOMERE family patents

30. Veklury patent expiration

VEKLURY family patents

31. Vonjo patent expiration

VONJO family patents

32. Voquezna patent expiration

VOQUEZNA family patents

33. Vtama patent expiration

VTAMA family patents

34. Xenoview patent expiration

XENOVIEW family patents

35. Xigduo Xr patent expiration

XIGDUO XR family patents

36. Zepbound patent expiration

ZEPBOUND family patents

37. Zepbound (autoinjector) patent expiration

ZEPBOUND (AUTOINJECTOR) family patents

38. Ztalmy patent expiration

ZTALMY family patents

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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. Bludigo patent expiration