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Last Updated: April 20, 2024

LAMIVUDINE Drug Patent Profile

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Which patents cover Lamivudine, and when can generic versions of Lamivudine launch?

Lamivudine is a drug marketed by 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, Mylan Labs Ltd, Strides Pharma, Upsher Smith Labs, Anda Repository, Chartwell Rx, Pharmacare, and Micro Labs. and is included in thirty-four NDAs.

The generic ingredient in LAMIVUDINE is lamivudine; nevirapine; zidovudine. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; nevirapine; zidovudine profile page.

Summary for LAMIVUDINE

US Patents:	0
Applicants:	20
NDAs:	34
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	639
Patent Applications:	2,772
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LAMIVUDINE
What excipients (inactive ingredients) are in LAMIVUDINE?	LAMIVUDINE excipients list
DailyMed Link:	LAMIVUDINE at DailyMed

Drug patent expirations by year for LAMIVUDINE

Drug Prices for LAMIVUDINE

Recent Clinical Trials for LAMIVUDINE

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

Sponsor	Phase
The Aurum Institute NPC	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A

See all LAMIVUDINE clinical trials

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

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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
Mylan	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	204005-001	Aug 28, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anda Repository	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	206375-001	Apr 10, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Micro Labs	LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE	lamivudine; nevirapine; zidovudine	TABLET;ORAL	205626-001	Aug 13, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	LAMIVUDINE	lamivudine	TABLET;ORAL	090457-002	Apr 19, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558-001	May 5, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	LAMIVUDINE	lamivudine	TABLET;ORAL	206974-001	Nov 21, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	LAMIVUDINE	lamivudine	SOLUTION;ORAL	077695-001	Nov 21, 2016	AA	RX	No	No	⤷ 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

EU/EMA Drug Approvals for LAMIVUDINE

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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

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