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Last Updated: January 22, 2020

DrugPatentWatch Database Preview

Lamivudine; zidovudine - Generic Drug Details

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What are the generic sources for lamivudine; zidovudine and what is the scope of patent protection?

Lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Anda Repository, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Pharmacare, Strides Pharma, and Teva Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine; zidovudine. Ten suppliers are listed for this compound. There are fourteen tentative approvals for this compound.

Recent Clinical Trials for lamivudine; zidovudine

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

SponsorPhase
Médecins Sans Frontières, BelgiumPhase 4
University of Cape TownPhase 4
Infectious Diseases Institute, UgandaPhase 3

See all lamivudine; zidovudine clinical trials

Recent Litigation for lamivudine; zidovudine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Lupin Ltd.2008-08-29
Plaintiff(s) v. Defendant(s)2008-01-31
Glaxo Group Ltd. v. Teva Pharmaceuticals USA Inc.2007-11-02

See all lamivudine; zidovudine litigation

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE
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.

US Patents and Regulatory Information for lamivudine; zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079079-001 Aug 12, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077411-001 Sep 7, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077558-001 May 5, 2017 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; zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997   Start Trial   Start Trial
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997   Start Trial   Start Trial
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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