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Last Updated: August 10, 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 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, 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

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

SponsorPhase
Chris Hani Baragwanath Academic HospitalPhase 2/Phase 3
Kalasin Hospital, KalasinPhase 2/Phase 3
AMS-CMU/IRD (PHPT)Phase 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
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 090679-001 Aug 29, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan LAMIVUDINE lamivudine TABLET;ORAL 204002-001 Dec 31, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079079-001 Aug 12, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 090246-001 May 15, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Arise LAMIVUDINE lamivudine TABLET;ORAL 206974-002 Nov 21, 2016 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
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998   Start Trial   Start Trial
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002   Start Trial   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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