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Last Updated: June 24, 2021

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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, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, 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.

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

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

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

See all lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
  Try Before You Buy  Try Before You Buy150MG; 300MG; 200MGTABLET; ORAL
  Try Before You Buy  Try Before You Buy150MG; 300MG; 600MGTABLET; ORAL
  Try Before You Buy  Try Before You Buy150MG; 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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Mylan Labs Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079079-001 Aug 12, 2019 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Strides Pharma LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128-001 May 13, 2015 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997   Try Before You Buy   Try Before You Buy
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Medtronic
McKinsey
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.