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Last Updated: March 29, 2024

Lamivudine; zidovudine - Generic Drug Details


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What are the generic drug 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, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharmacare, and Strides Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound. There are fourteen tentative approvals for this compound.

Summary for lamivudine; zidovudine
Recent Clinical Trials for lamivudine; zidovudine

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

SponsorPhase
Johns Hopkins UniversityPhase 1/Phase 2
The Aurum Institute NPCPhase 1/Phase 2
Médecins Sans Frontières, BelgiumPhase 2

See all lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial150MG; 300MG; 200MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial150MG; 300MG; 600MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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
Strides Pharma LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128-001 May 13, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 204005-001 Aug 28, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 090246-001 May 15, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 203259-001 Feb 3, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077411-001 Sep 7, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

EU/EMA Drug Approvals for lamivudine; zidovudine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva Pharma B.V.  Lamivudine/Zidovudine Teva lamivudine, zidovudine EMEA/H/C/001236
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Withdrawn yes no no 2011-02-28
ViiV Healthcare BV Combivir lamivudine, zidovudine EMEA/H/C/000190
Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,
Authorised no no no 1998-03-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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