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Lamivudine - Generic Drug Details

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What are the generic drug sources for lamivudine and what is the scope of patent protection?

Lamivudine is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma Ltd, Lannett Co Inc, Annora, Apotex, Arise, Cipla, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Strides Pharma, Micro Labs, Merck Sharp Dohme, Celltrion, Anda Repository, Hetero Labs Ltd Iii, Pharmacare, and Teva Pharms, and is included in forty-one NDAs. There are five 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. Twenty suppliers are listed for this compound. There are forty-five tentative approvals for this compound.

Summary for lamivudine

US Patents:	5
Tradenames:	10
Applicants:	22
NDAs:	41
Drug Master File Entries:	29
Suppliers / Packagers:	20
Bulk Api Vendors:	121
Clinical Trials:	567
Patent Applications:	3,806
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lamivudine
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
Advanced Pathogens Diagnostics Unit, University College London Hospitals	Phase 2/Phase 3
Department of Molecular and Clinical Pharmacology, University of Liverpool	Phase 2/Phase 3
MRC CTU at UCL	Phase 2/Phase 3

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

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
Lupin Ltd	LAMIVUDINE	lamivudine	TABLET;ORAL	205217-002	Dec 18, 2014	AB	RX	No	No
Apotex	LAMIVUDINE	lamivudine	TABLET;ORAL	202941-001	Jan 2, 2014	AB	RX	No	No
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No					Y
Aurobindo Pharma Ltd	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	202418-001	May 15, 2012	AB	RX	No	No
Strides Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079128-001	May 13, 2015	AB	RX	No	No
Celltrion	TEMIXYS	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	211284-001	Nov 16, 2018		RX	Yes	Yes

Expired US Patents for lamivudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002