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Last Updated: July 13, 2020

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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.

Drug Prices for lamivudine

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Recent Clinical Trials for lamivudine

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SponsorPhase
Advanced Pathogens Diagnostics Unit, University College London HospitalsPhase 2/Phase 3
Department of Molecular and Clinical Pharmacology, University of LiverpoolPhase 2/Phase 3
MRC CTU at UCLPhase 2/Phase 3

See all lamivudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial150MG; 300MG; 200MGTABLET; ORAL
  Start Trial  Start Trial150MG; 300MG; 600MGTABLET; ORAL
  Start Trial  Start Trial150MG; 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   Start Trial   Start Trial   Start Trial
Apotex LAMIVUDINE lamivudine TABLET;ORAL 202941-001 Jan 2, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No   Start Trial   Start Trial Y   Start Trial
Aurobindo Pharma Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 202418-001 May 15, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128-001 May 13, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Celltrion TEMIXYS lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 211284-001 Nov 16, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine SOLUTION;ORAL 020596-001 Nov 17, 1995   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Medtronic
Express Scripts
McKinsey
Mallinckrodt

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