EPIVIR Drug Patent Profile

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. Sixteen 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 APOTEX on December 2^nd, 2011.

Summary for EPIVIR

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	46
Patent Applications:	3,251
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
Bess Frost, PhD	Phase 1/Phase 2
Owens Medical Research Foundation	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		DISCN	Yes	No
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	TABLET;ORAL	020564-003	Jun 24, 2002
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995

EU/EMA Drug Approvals for EPIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Lamivudine Teva Pharma B.V.	lamivudine	EMEA/H/C/001111 Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.	Authorised	yes	no	no	2009-12-10
Teva B.V.	Lamivudine Teva	lamivudine	EMEA/H/C/001113 Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).	Authorised	yes	no	no	2009-10-23
GlaxoSmithKline (Ireland) Limited	Zeffix	lamivudine	EMEA/H/C/000242 Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., ,	Authorised	no	no	no	1999-07-29
ViiV Healthcare BV	Epivir	lamivudine	EMEA/H/C/000107 Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,	Authorised	no	no	no	1996-08-08

International Patents for EPIVIR

See the table below for patents covering EPIVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	129999	PHARMACEUTICAL COMPOSITION, PREPARATION PROCESS AND USE THEREOF
Austria	295150
Croatia	P980154	PHARMACEUTICAL COMPOSITIONS
Panama	8449301	COMPOSICIONES FARMACEUTICAS

Supplementary Protection Certificates for EPIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
2924034	CR 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126