Pharsight

1. Eliquis patents expiration

Application	Filing Date	Opposition Party	Legal Status

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

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9326945	April, 2018	Terminated-Settled	Pfizer Inc.	Mylan Pharmaceuticals Inc.
US6967208	August, 2015	Terminated-Denied	Bristol-Myers Squibb Company	Coalition for Affordable Drugs IX, 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.
US6967208	BRISTOL MYERS SQUIBB	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors	Nov, 2026 (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).
US9326945	BRISTOL MYERS SQUIBB	Apixaban formulations	Feb, 2031 (7 years from now)

Drugs and Companies using APIXABAN ingredient

Market Authorisation Date: 28 December, 2012

Treatment: Prophylaxis of deep vein thrombosis and pulmonary embolism; Reducing the risk of stroke and systemic embolism; Treatment of pulmonary embolism (pe); Reduce the risk of recurrent deep vein thrombosis (...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg and 5 mg	28 Dec, 2016	25	23 Dec, 2019	24 Feb, 2031	Eligible

Strength	Dosage	Availability
2.5MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription

ELIQUIS family patents

2. Sprycel patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP05722772A	2010-09-30	Gallafent, Antony Xavier	Patent maintained as amended
EP05722772A	2010-09-29	APOTEX INC.	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.
US7491725	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Mar, 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).
US8680103	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Feb, 2025 (1 year, 4 months from now)
US8680103 (Pediatric)	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Aug, 2025 (1 year, 10 months from now)
US7491725 (Pediatric)	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Sep, 2026 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2025
Pediatric Exclusivity (PED)	Jun 21, 2026

Drugs and Companies using DASATINIB ingredient

Market Authorisation Date: 28 June, 2006

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
80 mg and 140 mg	17 Jun, 2011	1	23 Nov, 2021	28 Mar, 2026	Non-Forfeiture
20 mg, 50 mg, 70 mg and 100 mg	28 Jun, 2010	1	10 Jun, 2016	28 Mar, 2026	Non-Forfeiture Deferred

Strength	Dosage	Availability
20MG	TABLET;ORAL	Prescription
50MG	TABLET;ORAL	Prescription
70MG	TABLET;ORAL	Prescription
80MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription
140MG	TABLET;ORAL	Prescription

SPRYCEL family patents

3. Zerit Xr patents 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).
US7135465	BRISTOL MYERS SQUIBB	Sustained release beadlets containing stavudine	Feb, 2023 (7 months ago)
US7135465 (Pediatric)	BRISTOL MYERS SQUIBB	Sustained release beadlets containing stavudine	Aug, 2023 (a month ago)

Drugs and Companies using STAVUDINE ingredient

Market Authorisation Date: 31 December, 2002

Treatment: Method for treating hiv-1 infection

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
37.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
50MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
75MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued
100MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued