Pharsight

1. Baraclude 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).
US5206244	BRISTOL MYERS SQUIBB	Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines	Feb, 2015 (9 years ago)
US5206244 (Pediatric)	BRISTOL MYERS SQUIBB	Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines	Aug, 2015 (8 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Sep 20, 2017
New Dosing Schedule(D-127)	Oct 15, 2013
New Patient Population(NPP)	Oct 12, 2015

Drugs and Companies using ENTECAVIR ingredient

Market Authorisation Date: 29 March, 2005

Treatment: NA

Dosage: TABLET;ORAL; SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg and 1 mg	14 Jun, 2010	1	26 Aug, 2014	21 Aug, 2015	Eligible

Strength	Dosage	Availability
0.5MG	TABLET;ORAL	Prescription
1MG	TABLET;ORAL	Prescription
0.05MG/ML	SOLUTION;ORAL	Prescription

BARACLUDE family patents

2. 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 (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).
US6413980	BRISTOL MYERS SQUIBB	Nitrogen containing heterobicycles as factor Xa inhibitors	Dec, 2019 (4 years ago)
US9326945	BRISTOL MYERS SQUIBB	Apixaban formulations	Feb, 2031 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-690)	Aug 21, 2017
New Indication(I-661)	Aug 21, 2017
New Indication(I-691)	Aug 21, 2017
New Indication(I-681)	Mar 03, 2017
New Chemical Entity Exclusivity(NCE)	Dec 28, 2017

Drugs and Companies using APIXABAN ingredient

NCE-1 date: 28 December, 2016

Market Authorisation Date: 28 December, 2012

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

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

3. Glucovance 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).
US6303146	BRISTOL MYERS SQUIBB	Solid oral dosage form comprising a combination of metformin and glibenclamide	Jul, 2019 (4 years ago)
US6303146 (Pediatric)	BRISTOL MYERS SQUIBB	Solid oral dosage form comprising a combination of metformin and glibenclamide	Jan, 2020 (4 years ago)

Drugs and Companies using GLYBURIDE; METFORMIN HYDROCHLORIDE ingredient

Market Authorisation Date: 31 July, 2000

Treatment: Treatment of type 2 diabetes

Dosage: TABLET;ORAL

Strength	Dosage	Availability
1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued

GLUCOVANCE family patents

4. Idhifa patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10610125	August, 2022	Terminated-Settled	Servier Pharmaceuticals LLC et al.	Rigel Pharmaceuticals, Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9512107	BRISTOL MYERS SQUIBB	Therapeutically active compositions and their methods of use	Jan, 2033 (8 years from now)
US10093654	BRISTOL MYERS SQUIBB	Therapeutically active compounds and their methods of use	Aug, 2034 (10 years from now)
US9738625	BRISTOL MYERS SQUIBB	Therapeutically active compounds and their methods of use	Aug, 2034 (10 years from now)
US9732062	BRISTOL MYERS SQUIBB	Therapeutically active compounds and their methods of use	Sep, 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).
US10610125	BRISTOL MYERS SQUIBB	Methods and compositions for cell-proliferation-related disorders	Jun, 2030 (6 years from now)
US10294215	BRISTOL MYERS SQUIBB	Therapeutically active compounds and their methods of use	Jan, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-151)	Aug 01, 2024
Orphan Drug Exclusivity(ODE)	Aug 01, 2024
New Chemical Entity Exclusivity(NCE)	Aug 01, 2022

Drugs and Companies using ENASIDENIB MESYLATE ingredient

NCE-1 date: 01 August, 2021

Market Authorisation Date: 01 August, 2017

Treatment: Treatment of relapsed or refractory acute myeloid leukemia (aml) with an isocitrate dehydrogenase-2 (idh2) mutation

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 50MG BASE	TABLET;ORAL	Prescription
EQ 100MG BASE	TABLET;ORAL	Prescription

IDHIFA family patents

5. Pravachol 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).
US5622985	BRISTOL MYERS SQUIBB	Method for preventing a second heart attack employing an HMG CoA reductase inhibitor	Apr, 2014 (10 years ago)
US5622985 (Pediatric)	BRISTOL MYERS SQUIBB	Method for preventing a second heart attack employing an HMG CoA reductase inhibitor	Oct, 2014 (9 years ago)

Drugs and Companies using PRAVASTATIN SODIUM ingredient

Market Authorisation Date: 31 October, 1991

Treatment: Use of pravastatin sodium for secondary prevention of coronary events in men and women who have had a myocardial infarction and have normal cholesterol levels

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg, 20 mg, 40 mg and 80 mg
30 mg	01 Jun, 2005	1	28 Nov, 2006	22 Apr, 2014	Eligible

Strength	Dosage	Availability
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued

PRAVACHOL family patents

6. Pravigard Pac (copackaged) 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).
US5622985	BRISTOL MYERS SQUIBB	Method for preventing a second heart attack employing an HMG CoA reductase inhibitor	Apr, 2014 (10 years ago)
US5622985 (Pediatric)	BRISTOL MYERS SQUIBB	Method for preventing a second heart attack employing an HMG CoA reductase inhibitor	Oct, 2014 (9 years ago)

Drugs and Companies using ASPIRIN; PRAVASTATIN SODIUM ingredient

Market Authorisation Date: 24 June, 2003

Treatment: Use of pravastatin sodium for secondary prevention of coronary events in men and women who have had a myocardial infarction and have normal cholesterol levels

Dosage: TABLET;ORAL

Strength	Dosage	Availability
325MG;20MG	TABLET;ORAL	Discontinued
325MG;80MG	TABLET;ORAL	Discontinued
81MG;40MG	TABLET;ORAL	Discontinued
81MG;20MG	TABLET;ORAL	Discontinued
81MG;80MG	TABLET;ORAL	Discontinued
325MG;40MG	TABLET;ORAL	Discontinued

PRAVIGARD PAC (COPACKAGED) family patents

7. Revlimid patents expiration

Application	Filing Date	Opposition Party	Legal Status

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
EP09008756A	2015-07-22	Accord Healthcare Ltd	Revoked
EP09008756A	2015-07-21	Hexal AG	Revoked
EP09008756A	2015-07-21	Generics [UK] Limited (trading as Mylan)	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

US7968569	September, 2018	Terminated-Denied	Celgene Corporation	Alvogen Pine Brook LLC
US9056120	August, 2018	Terminated-Denied	Celgene Corporation	Dr. Reddy's Laboratories, Inc.
US8404717	August, 2018	Terminated-Denied	Celgene Corporation	Dr. Reddy's Laboratories, Inc
US7189740	August, 2018	Terminated-Denied	Celgene Corporation	Dr. Reddy's Laboratories, Inc.
US8741929	February, 2018	Terminated-Denied	Celgene Corporation	Apotex Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8288415	BRISTOL MYERS SQUIBB	Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione	Jul, 2016 (7 years ago)
US5635517	BRISTOL MYERS SQUIBB	Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines	Oct, 2019 (4 years ago)
US7855217	BRISTOL MYERS SQUIBB	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione	Nov, 2024 (6 months from now)
US7465800	BRISTOL MYERS SQUIBB	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione	Apr, 2027 (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).
US6555554	BRISTOL MYERS SQUIBB	Isoindolines, method of use, and pharmaceutical compositions	Jul, 2016 (7 years ago)
US6281230	BRISTOL MYERS SQUIBB	Isoindolines, method of use, and pharmaceutical compositions	Jul, 2016 (7 years ago)
US8288415	BRISTOL MYERS SQUIBB	Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione	Jul, 2016 (7 years ago)
US7119106	BRISTOL MYERS SQUIBB	Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline	Jul, 2016 (7 years ago)
US6561976	BRISTOL MYERS SQUIBB	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (5 years ago)
US6908432	BRISTOL MYERS SQUIBB	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (5 years ago)
US8589188	BRISTOL MYERS SQUIBB	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (5 years ago)
US8204763	BRISTOL MYERS SQUIBB	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (5 years ago)
US6045501	BRISTOL MYERS SQUIBB	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug	Aug, 2018 (5 years ago)
US5635517	BRISTOL MYERS SQUIBB	Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines	Oct, 2019 (4 years ago)
US8315886	BRISTOL MYERS SQUIBB	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 MYERS SQUIBB	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 MYERS SQUIBB	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)
US6561977	BRISTOL MYERS SQUIBB	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 MYERS SQUIBB	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)
US7189740	BRISTOL MYERS SQUIBB	Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes	Apr, 2023 (1 year, 23 days ago)
US8404717	BRISTOL MYERS SQUIBB	Methods of treating myelodysplastic syndromes using lenalidomide	Apr, 2023 (1 year, 23 days ago)
US9056120	BRISTOL MYERS SQUIBB	Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine	Apr, 2023 (1 year, 23 days ago)
US9101621	BRISTOL MYERS SQUIBB	Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation	May, 2023 (11 months ago)
US9155730	BRISTOL MYERS SQUIBB	Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent	May, 2023 (11 months ago)
US9393238	BRISTOL MYERS SQUIBB	Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent	May, 2023 (11 months ago)
US9101622	BRISTOL MYERS SQUIBB	Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone	May, 2023 (11 months ago)
US8648095	BRISTOL MYERS SQUIBB	Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor	May, 2023 (11 months ago)
US8530498	BRISTOL MYERS SQUIBB	Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione	May, 2023 (11 months ago)
US7468363	BRISTOL MYERS SQUIBB	Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione	Oct, 2023 (6 months ago)
US7968569	BRISTOL MYERS SQUIBB	Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione	Oct, 2023 (6 months ago)
US8492406	BRISTOL MYERS SQUIBB	Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione	Oct, 2023 (6 months ago)
US8741929	BRISTOL MYERS SQUIBB	Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas	Mar, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-131)	Feb 22, 2024
Orphan Drug Exclusivity(ODE-241)	May 28, 2026
Orphan Drug Exclusivity(ODE-245)	May 28, 2026
New Indication(I-706)	Feb 17, 2018
New Indication(I-796)	May 28, 2022
New Indication(I-797)	May 28, 2022
Orphan Drug Exclusivity(ODE-49)	Jun 05, 2020
Orphan Drug Exclusivity(ODE-88)	Feb 17, 2022
New Indication(I-672)	Jun 05, 2016
Orphan Drug Exclusivity(ODE)	Jun 05, 2020
New Strength(NS)	Jun 05, 2016

Drugs and Companies using LENALIDOMIDE ingredient

Market Authorisation Date: 21 December, 2011

Treatment: Use of revlimid (lenalidomide) to inhibit the secretion of pro-inflammatory cytokines, including tumor necrosis factor alpha; Use of revlimid (lenalidomide) for the treatment of multiple myeloma and t...

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg, 10 mg and 15 mg	30 Aug, 2010	1	21 May, 2021	27 Apr, 2027	Non-Forfeiture
25 mg	12 Jul, 2010	1	21 May, 2021	27 Apr, 2027	Non-Forfeiture
2.5 mg and 20 mg	12 Jul, 2016	1	14 Oct, 2021	27 Apr, 2027	Non-Forfeiture

Strength	Dosage	Availability
5MG	CAPSULE;ORAL	Prescription
25MG	CAPSULE;ORAL	Prescription
20MG	CAPSULE;ORAL	Prescription
2.5MG	CAPSULE;ORAL	Prescription
10MG	CAPSULE;ORAL	Prescription
15MG	CAPSULE;ORAL	Prescription

REVLIMID family patents

8. Reyataz patents 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.
US5849911	BRISTOL MYERS SQUIBB	Antivirally active heterocyclic azahexane derivatives	Jun, 2017 (6 years ago)
US6087383	BRISTOL MYERS SQUIBB	Bisulfate salt of HIV protease inhibitor	Dec, 2018 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5849911	BRISTOL MYERS SQUIBB	Antivirally active heterocyclic azahexane derivatives	Jun, 2017 (6 years ago)
US5849911 (Pediatric)	BRISTOL MYERS SQUIBB	Antivirally active heterocyclic azahexane derivatives	Dec, 2017 (6 years ago)
US6087383	BRISTOL MYERS SQUIBB	Bisulfate salt of HIV protease inhibitor	Dec, 2018 (5 years ago)
US6087383 (Pediatric)	BRISTOL MYERS SQUIBB	Bisulfate salt of HIV protease inhibitor	Jun, 2019 (4 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosing Schedule(D-116)	Sep 30, 2011
New Dosing Schedule(D-130)	Feb 04, 2014

Drugs and Companies using ATAZANAVIR SULFATE ingredient

Market Authorisation Date: 20 June, 2003

Treatment: Method for treating hiv-1 infection

Dosage: CAPSULE;ORAL; POWDER;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 150 mg	19 Mar, 2010	1	22 Apr, 2014	21 Dec, 2018	Eligible
200 mg	16 Feb, 2010	1	22 Apr, 2014	21 Dec, 2018	Eligible
300 mg	20 Jul, 2009	1	22 Apr, 2014	21 Dec, 2018	Eligible

Strength	Dosage	Availability
EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued
EQ 50MG BASE/PACKET	POWDER;ORAL	Prescription
EQ 300MG BASE	CAPSULE;ORAL	Prescription
EQ 200MG BASE	CAPSULE;ORAL	Prescription
EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued

REYATAZ family patents

9. 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 (1 year, 10 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7125875	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Apr, 2020 (4 years ago)
US7153856	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Apr, 2020 (4 years ago)
US6596746	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Jun, 2020 (3 years ago)
US7125875 (Pediatric)	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Oct, 2020 (3 years ago)
US7153856 (Pediatric)	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Oct, 2020 (3 years ago)
US6596746 (Pediatric)	BRISTOL MYERS SQUIBB	Cyclic protein tyrosine kinase inhibitors	Dec, 2020 (3 years ago)
US8680103	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Feb, 2025 (9 months from now)
US8680103 (Pediatric)	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Aug, 2025 (1 year, 3 months from now)
US7491725 (Pediatric)	BRISTOL MYERS SQUIBB	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors	Sep, 2026 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-225)	Dec 21, 2025
Pediatric Exclusivity(PED)	Jun 21, 2026
Orphan Drug Exclusivity(ODE-164)	Nov 09, 2024
New Patient Population(NPP)	Nov 09, 2020
New Indication(I-791)	Dec 21, 2021
New Dosing Schedule(D-120)	May 21, 2012
M(M-94)	Oct 28, 2013
Orphan Drug Exclusivity(ODE)	Jun 28, 2013

Drugs and Companies using DASATINIB ingredient

Market Authorisation Date: 28 June, 2006

Treatment: A method for the treatment of cancer; A method for the treatment of a protein tyrosine kinase-associated disorder

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
50MG	TABLET;ORAL	Prescription
80MG	TABLET;ORAL	Prescription
20MG	TABLET;ORAL	Prescription
70MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription
140MG	TABLET;ORAL	Prescription

SPRYCEL family patents

10. Sustiva 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).
US5811423	BRISTOL MYERS SQUIBB	Benzoxazinones as inhibitors of HIV reverse transcriptase	Aug, 2012 (11 years ago)
US5519021	BRISTOL MYERS SQUIBB	Benzoxazinones as inhibitors of HIV reverse transcriptase	May, 2013 (10 years ago)
US5519021 (Pediatric)	BRISTOL MYERS SQUIBB	Benzoxazinones as inhibitors of HIV reverse transcriptase	Nov, 2013 (10 years ago)
US5663169	BRISTOL MYERS SQUIBB	Benzoxazinones as inhibitors of HIV reverse transcriptase	Sep, 2014 (9 years ago)
US5663169 (Pediatric)	BRISTOL MYERS SQUIBB	Benzoxazinones as inhibitors of HIV reverse transcriptase	Mar, 2015 (9 years ago)
US6939964	BRISTOL MYERS SQUIBB	Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one	Jan, 2018 (6 years ago)
US6639071	BRISTOL MYERS SQUIBB	Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one	Feb, 2018 (6 years ago)
US6939964 (Pediatric)	BRISTOL MYERS SQUIBB	Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one	Jul, 2018 (5 years ago)
US6639071 (Pediatric)	BRISTOL MYERS SQUIBB	Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one	Aug, 2018 (5 years ago)
US6238695	BRISTOL MYERS SQUIBB	Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants	Apr, 2019 (5 years ago)
US6555133	BRISTOL MYERS SQUIBB	Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants	Apr, 2019 (5 years ago)
US6238695 (Pediatric)	BRISTOL MYERS SQUIBB	Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants	Oct, 2019 (4 years ago)
US6555133 (Pediatric)	BRISTOL MYERS SQUIBB	Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants	Oct, 2019 (4 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	May 02, 2016
Pediatric Exclusivity(PED)	Nov 02, 2016

Drugs and Companies using EFAVIRENZ ingredient

Market Authorisation Date: 17 September, 1998

Treatment: Treatment of hiv infection in combination with one or more additional hiv antiviral agents; Treatment of hiv

Dosage: CAPSULE;ORAL; TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
600 mg	09 Apr, 2009	1	17 Feb, 2016	20 Jan, 2018	Eligible
50 mg, 100 mg and 200 mg	03 Nov, 2016	1	15 Dec, 2017	06 Apr, 2019	Eligible

Strength	Dosage	Availability
50MG	CAPSULE;ORAL	Discontinued
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued
200MG	CAPSULE;ORAL	Discontinued
600MG	TABLET;ORAL	Discontinued
300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued

SUSTIVA family patents

11. 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 (1 year, 2 months ago)
US7135465 (Pediatric)	BRISTOL MYERS SQUIBB	Sustained release beadlets containing stavudine	Aug, 2023 (8 months 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

Pharsight

Bristol Myers Squibb patents expiration

1. Baraclude patents expiration

BARACLUDE family patents

2. Eliquis patents expiration

ELIQUIS family patents

3. Glucovance patents expiration

GLUCOVANCE family patents

4. Idhifa patents expiration

IDHIFA family patents

5. Pravachol patents expiration

PRAVACHOL family patents

6. Pravigard Pac (copackaged) patents expiration

PRAVIGARD PAC (COPACKAGED) family patents

7. Revlimid patents expiration

REVLIMID family patents

8. Reyataz patents expiration

REYATAZ family patents

9. Sprycel patents expiration

SPRYCEL family patents

10. Sustiva patents expiration

SUSTIVA family patents

11. Zerit Xr patents expiration

ZERIT XR family patents

Related content

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