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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. Twenty suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

US ANDA 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:	120
Clinical Trials:	29
Patent Applications:	2,382
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIVIR
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
Instituto de Investigación Hospital Universitario La Paz	Phase 2
GlaxoSmithKline	Phase 1/Phase 2
University of Michigan Cancer Center	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
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	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	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	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

International Patents for EPIVIR

Country	Patent Number	Estimated Expiration
European Patent Office	1099700
Guatemala	199800052
African Regional IP Organization (ARIPO)	9000163
Bosnia and Herzegovina	96098
Japan	H1180153

Supplementary Protection Certificates for EPIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
0513917	SPC/GB98/019	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
2924034	19C1025	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126
0382526	SPC/GB96/043	United Kingdom		PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126