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Last Updated: May 20, 2022

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, 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. Seventeen suppliers are listed for this compound. There are forty-five tentative approvals for this compound.

Drug Prices for lamivudine

See drug prices for lamivudine

Recent Clinical Trials for lamivudine

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

SponsorPhase
Johns Hopkins UniversityPhase 1/Phase 2
The Aurum Institute NPCPhase 1/Phase 2
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.Phase 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
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma LAMIVUDINE lamivudine TABLET;ORAL 090457-001 Apr 19, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 AB RX Yes Yes 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
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 See Plans and Pricing See Plans and Pricing
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 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

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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