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EPIVIR Drug Profile

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Which patents cover Epivir, and when can generic versions of Epivir launch?

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs.

The generic ingredient in EPIVIR is lamivudine. There are twenty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epivir

A generic version of EPIVIR was approved as lamivudine by AUROBINDO PHARMA LTD on November 17^th, 2011.

Summary for EPIVIR

US Patents:	0
Applicants:	2
NDAs:	4
Suppliers / Packagers:	1
Bulk Api Vendors:	126
Clinical Trials:	31
Patent Applications:	3,569
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIVIR
What excipients (inactive ingredients) are in EPIVIR?	EPIVIR excipients list
DailyMed Link:	EPIVIR at DailyMed

See drug prices for EPIVIR

Recent Clinical Trials for EPIVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Roswell Park Cancer Institute	Phase 2
Owens Medical Research Foundation	Phase 1/Phase 2
Bess Frost, PhD	Phase 1/Phase 2

See all EPIVIR clinical trials

Pharmacology for EPIVIR

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	AA	RX	Yes	Yes
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	AB	RX	Yes	Yes

Expired US Patents for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995

International Patents for EPIVIR

Country	Patent Number	Estimated Expiration
African Regional IP Organization (ARIPO)	9200395
Guatemala	199800052
African Intellectual Property Organization (OAPI)	9913
European Patent Office	1099700

Supplementary Protection Certificates for EPIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE
2924034	LUC00114	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126