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Last Updated: April 21, 2021

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Lamivudine; nevirapine; zidovudine - Generic Drug Details

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

Lamivudine; nevirapine; zidovudine is the generic ingredient in one branded drug marketed by Micro Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine; nevirapine; zidovudine. There are seven tentative approvals for this compound.

Summary for lamivudine; nevirapine; zidovudine
US Patents:0
Drug Master File Entries: 29
Clinical Trials: 43
DailyMed Link:lamivudine; nevirapine; zidovudine at DailyMed
Recent Clinical Trials for lamivudine; nevirapine; zidovudine

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

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 4
PfizerPhase 4
Imperial College LondonPhase 4

See all lamivudine; nevirapine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial150MG; 200MG; 300MGTABLET; ORAL
  Start Trial  Start Trial150MG; 200MG; 300MGTABLET; ORAL
  Start Trial  Start Trial30MG; 50MG; 60MGTABLET, FOR SUSPENSION; 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; nevirapine; zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE lamivudine; nevirapine; zidovudine TABLET;ORAL 205626-001 Aug 13, 2018 DISCN Yes 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

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