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Last Updated: May 16, 2021

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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 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, Arise, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharma Life, 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. Nineteen 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
Fundação Bahiana de InfectologiaPhase 3
Chris Hani Baragwanath Academic HospitalPhase 2/Phase 3
Kalasin Hospital, KalasinPhase 2/Phase 3

See all LAMIVUDINE clinical trials

Generic filers with tentative approvals for LAMIVUDINE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $10150MG; 300MG; 200MGTABLET; ORAL
  Get Started for $10  Get Started for $10150MG; 300MG; 600MGTABLET; ORAL
  Get Started for $10  Get Started for $10150MG; 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
Arise LAMIVUDINE lamivudine TABLET;ORAL 206974-002 Nov 21, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Hetero Labs Ltd Iii LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079124-001 Sep 17, 2015 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Arise LAMIVUDINE lamivudine TABLET;ORAL 206974-001 Nov 21, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998   Get Started for $10   Get Started for $10
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995   Get Started for $10   Get Started for $10
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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