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Last Updated: March 18, 2024

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 freedom to operate?

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 seven tentative approvals for this compound.

Summary for lamivudine; nevirapine; zidovudine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 45
DailyMed Link:lamivudine; nevirapine; zidovudine at DailyMed
Recent Clinical Trials for lamivudine; nevirapine; zidovudine

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

SponsorPhase
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 4

See all lamivudine; nevirapine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial150MG; 200MG; 300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial150MG; 200MG; 300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 ⤷  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

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