EPIVIR Drug Patent 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. 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.

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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:	2,772
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

Drug patent expirations by year 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

Anatomical Therapeutic Chemical (ATC) Classes for EPIVIR

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for EPIVIR

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EPIVIR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for EPIVIR

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for EPIVIR

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

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Country	Patent Number	Title	Estimated Expiration
Slovakia	283430		⤷ Try a Trial
Hungary	210537		⤷ Try a Trial
Slovenia	0969815		⤷ Try a Trial
South Africa	9103293		⤷ Try a Trial
Ireland	71225	2-substituted-4-substituted-1,3-dioxolanes synthesis and use thereof	⤷ Try a Trial
Germany	69034119		⤷ Try a Trial
Poland	167682		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EPIVIR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0382526	SPC/GB96/043	United Kingdom	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034	1990024-0	Sweden	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2924034	2019/021	Ireland	⤷ Try a Trial	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
0513917	98C0020	Belgium	⤷ Try a Trial	PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0513917	SPC/GB98/019	United Kingdom	⤷ Try a Trial	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	CR 2019 00024	Denmark	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for EPIVIR

Recent Clinical Trials for EPIVIR

Pharmacology for EPIVIR

Anatomical Therapeutic Chemical (ATC) Classes for EPIVIR

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