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Last Updated: June 28, 2022

Lamivudine; zidovudine - Generic Drug Details


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What are the generic sources for lamivudine; zidovudine and what is the scope of freedom to operate?

Lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Anda Repository, 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.

Eleven 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
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
Wellcome TrustPhase 2

See all lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150MG; 300MG; 200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing150MG; 300MG; 600MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing150MG; 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
Hetero Labs Ltd V LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 203259-001 Feb 3, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077558-001 May 5, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 202418-001 May 15, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anda Repository LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 206375-001 Apr 10, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079124-001 Sep 17, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.
Authorised 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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