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Last Updated: June 6, 2020

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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.

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
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 202418-001 May 15, 2012 AB RX No 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
Pharmacare LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 022018-001 Mar 17, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare COMBIVIR lamivudine; zidovudine TABLET;ORAL 020857-001 Sep 26, 1997 AB RX Yes Yes   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
Hetero Labs Ltd Iii LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079124-001 Sep 17, 2015 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

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Medtronic
McKinsey
Mallinckrodt
Express Scripts

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