LAMIVUDINE - Generic Drug Details

What are the generic drug sources for lamivudine and what is the scope of freedom to operate?

Lamivudine is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan Labs Ltd, Natco, Strides Pharma, Upsher Smith Labs, Micro Labs, Merck Sharp Dohme, Chartwell Rx, Epic Pharma Llc, Norvium Bioscience, and Pharmacare, and is included in forty-two NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine. Sixteen suppliers are listed for this compound. There are forty-four tentative approvals for this compound.

Summary for LAMIVUDINE

US Patents:	2
Tradenames:	10
Applicants:	24
NDAs:	42
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	641
Patent Applications:	6,536
Drug Prices:	Drug price trends for LAMIVUDINE
What excipients (inactive ingredients) are in LAMIVUDINE?	LAMIVUDINE excipients list
DailyMed Link:	LAMIVUDINE at DailyMed

See drug prices for LAMIVUDINE

Recent Clinical Trials for LAMIVUDINE

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

Sponsor	Phase
University of Wisconsin, Madison	Early Phase 1
Johns Hopkins University	Phase 1/Phase 2
The Aurum Institute NPC	Phase 1/Phase 2

See all LAMIVUDINE clinical trials

Generic filers with tentative approvals for LAMIVUDINE

Applicant	Application No.	Strength	Dosage Form
		150MG; 300MG; 200MG	TABLET; ORAL
		150MG; 300MG; 600MG	TABLET; ORAL
		150MG; 300MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LAMIVUDINE

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

Medical Subject Heading (MeSH) Categories for LAMIVUDINE

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LAMIVUDINE

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 LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	LAMIVUDINE	lamivudine	TABLET;ORAL	091606-001	Dec 2, 2011	AB	RX	No	No
Cipla	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077411-001	Sep 7, 2018	AB	RX	No	No
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No
Epic Pharma Llc	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	206375-001	Apr 10, 2018	AB	RX	No	No

Expired US Patents for LAMIVUDINE

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	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995

EU/EMA Drug Approvals for LAMIVUDINE

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