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 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

Sponsor	Phase
Johns Hopkins University	Phase 1/Phase 2
The Aurum Institute NPC	Phase 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
⤷ Sign Up	⤷ Sign Up	150MG; 200MG; 300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	150MG; 200MG; 300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	30MG; 50MG; 60MG	TABLET, 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.

Anatomical Therapeutic Chemical (ATC) Classes for lamivudine; nevirapine; zidovudine

US Patents and Regulatory Information for lamivudine; nevirapine; zidovudine

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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