Is there a generic for Nevirapine?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Nevirapine, referencing the brand VIRAMUNE XR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nevirapine?

VIRAMUNE XR (NDA 201152, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Nevirapine?

The Orange Book lists 1 patent against Nevirapine products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Nevirapine are approved?

Nevirapine is approved in the following dosage forms: suspension, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Nevirapine

Nevirapine is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VIRAMUNE XR · NDA 201152

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
VIRAMUNE XRRLD×2	BOEHRINGER INGELHEIM	NDA 201152	—	Nov 08, 2012
VIRAMUNERLD	BOEHRINGER INGELHEIM	NDA 020933	—	Sep 11, 1998
VIRAMUNERLD	BOEHRINGER INGELHEIM	NDA 020636	—	Jun 21, 1996

Generic (ANDA) products (23)

Product	Applicant	Application	TE	Approved
NEVIRAPINE	MACLEODS PHARMS LTD	ANDA 090688	AB	Jan 14, 2019
NEVIRAPINE	MACLEODS PHARMS LTD	ANDA 206879	AB	Oct 06, 2017
NEVIRAPINE	CIPLA	ANDA 207684	AA	Aug 03, 2017
NEVIRAPINE×2	TECH ORGANIZED	ANDA 207467	—	Jul 31, 2017
NEVIRAPINE	AUROBINDO PHARMA	ANDA 207698	—	Feb 28, 2017
NEVIRAPINE	AUROBINDO PHARMA	ANDA 208616	—	Nov 23, 2016
NEVIRAPINE×2	ALVOGEN	ANDA 204621	—	Nov 09, 2015
NEVIRAPINE	PHARMOBEDIENT	ANDA 206271	—	Nov 09, 2015
NEVIRAPINE	CIPLA	ANDA 206448	—	Oct 15, 2015
NEVIRAPINE	MYLAN	ANDA 205651	AB	Oct 27, 2014
NEVIRAPINE	APOTEX	ANDA 205258	—	Apr 03, 2014
NEVIRAPINE	SANDOZ	ANDA 203411	AB	Apr 03, 2014
NEVIRAPINE	AUROBINDO	ANDA 077702	AA	May 22, 2012
NEVIRAPINE	APOTEX INC	ANDA 203021	—	May 22, 2012
NEVIRAPINE	AUROBINDO	ANDA 077521	AB	May 22, 2012
NEVIRAPINE	CIPLA	ANDA 077956	AB	May 22, 2012
NEVIRAPINE	HETERO LABS LTD III	ANDA 078584	AB	May 22, 2012
NEVIRAPINE	MICRO LABS LTD	ANDA 203080	AB	May 22, 2012
NEVIRAPINE	MYLAN PHARMS INC	ANDA 202523	AB	May 22, 2012
NEVIRAPINE	PHARMOBEDIENT	ANDA 078864	—	May 22, 2012
NEVIRAPINE	PRINSTON INC	ANDA 078644	—	May 22, 2012
NEVIRAPINE	STRIDES PHARMA	ANDA 078195	—	May 22, 2012
NEVIRAPINE	TECH ORGANIZED	ANDA 203176	—	May 22, 2012

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8460704	Mar 12, 2029	in 2 yr 9 mo	U-1409

Nevirapine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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