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Last Updated: April 16, 2021

DrugPatentWatch Database Preview

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, 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.

Summary for lamivudine
Drug Prices for lamivudine

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Recent Clinical Trials for lamivudine

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SponsorPhase
Fundação Bahiana de InfectologiaPhase 3
Baylor College of MedicinePhase 2/Phase 3
Great Ormond Street Hospital for Children NHS Foundation TrustPhase 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
Arise LAMIVUDINE lamivudine TABLET;ORAL 206974-001 Nov 21, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LAMIVUDINE lamivudine TABLET;ORAL 202032-001 Nov 17, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd LAMIVUDINE lamivudine TABLET;ORAL 205217-002 Dec 18, 2014 AB RX No No   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 SOLUTION;ORAL 020596-001 Nov 17, 1995   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998   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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