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Last Updated: June 30, 2022

LAMIVUDINE - Generic Drug Details


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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 Ltd, Lannett Co Inc, Annora, Apotex, Appco, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Strides Pharma, Micro Labs, Merck Sharp Dohme, Celltrion, Anda Repository, Chartwell Rx, Hetero Labs Ltd Iii, and Pharmacare, 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. Sixteen suppliers are listed for this compound. There are forty-five tentative approvals for this compound.

Drug Prices for LAMIVUDINE

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Recent Clinical Trials for LAMIVUDINE

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

SponsorPhase
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
University College, LondonPhase 3

See all LAMIVUDINE clinical trials

Generic filers with tentative approvals for LAMIVUDINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150MG; 300MG; 200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing150MG; 300MG; 600MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing150MG; 300MG; 300MGTABLET; ORAL

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

Medical Subject Heading (MeSH) Categories for LAMIVUDINE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128-001 May 13, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 204005-001 Aug 28, 2014 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 LAMIVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

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