Nevirapine

Sold as Viramune, Nevirapine Tablets For Oral Suspension, Viramune Xr, Nevirapine. Every FDA application for this active ingredient: 5 branded and 27 generic.

As of Nov 15, 2026, FDA lists 32 applications for Nevirapine (sold as Viramune, Nevirapine Tablets For Oral Suspension, Viramune Xr and others), first approved Jun 21, 1996, with 8 new uses approved and 0 published complete response letters.

First approved: Jun 21, 1996
Applications: 32
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $1.3M
First approved in the EU: Feb 4, 1998

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Nevirapine ER	Part D	$1.0M	-29%	721
Nevirapine	Part D	$289K	+1%	794

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

NEVIRAPINE 200 MG TABLET: $0.147 per unitGeneric · +10% in a year
NEVIRAPINE ER 400 MG TABLET: $1.63 per unitGeneric · +8% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Prevention of HIV infection in pediatric patients under the age of 16 yearsAuritec Pharmaceuticals · designated Nov 25, 2009

Approvals in the EU (EMA)

First approved in the EU 19 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Nevirapine Teva, genericTeva B.V. · Nov 30, 2009 · withdrawn
Viramune, new substanceBoehringer Ingelheim International GmbH · Feb 4, 1998

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Research on the Psychological Status of Patients With HIV-1 InfectionHIV-1-infection, Anxiety Depression · Shanxi Bethune Hospital	—	Not yet recruiting	Jul 23, 2025
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV TreatmentsHIV-1-infection · Gilead Sciences	Phase 4	Recruiting	Mar 29, 2024
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)HIV-1-infection · Gilead Sciences	Phase 2 / Phase 3	Active, not recruiting	Aug 16, 2022
Early Infant HIV Treatment in BotswanaHIV, Pediatric AIDS · Harvard School of Public Health (HSPH)	Phase 2 / Phase 3	Active, not recruiting	Feb 24, 2015
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV RemissionHIV Infection · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1 / Phase 2	Recruiting	May 16, 2014
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIVAcquired Immune Deficiency Syndrome (AIDS), HIV Infections · Gilead Sciences	Phase 2 / Phase 3	Active, not recruiting	Dec 20, 2013

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 21, 1996	ViramuneNDA 20636 · New molecular entity	Boehringer Ingelheim	35	Discontinued
Sep 11, 1998	ViramuneNDA 20933 · New dosage form	Boehringer Ingelheim	29	Discontinued
Mar 25, 2011	Viramune XrNDA 201152 · New dosage form	Boehringer Ingelheim	9	Discontinued
May 22, 2012	NevirapineANDA 77521	Aurobindo	6	Marketed
May 22, 2012	NevirapineANDA 77956	Cipla	6	Marketed
May 22, 2012	NevirapineANDA 78195	Strides Pharma	1	Discontinued
May 22, 2012	NevirapineANDA 78584	Hetero Labs Ltd Iii	5	Marketed
May 22, 2012	NevirapineANDA 78644	Prinston Inc	4	Discontinued
May 22, 2012	NevirapineANDA 78864	Pharmobedient	0	Discontinued
May 22, 2012	NevirapineANDA 202523	Mylan Pharms Inc	4	Marketed
May 22, 2012	NevirapineANDA 203021	Apotex Inc	2	Discontinued
May 22, 2012	NevirapineANDA 203080	Micro Labs Ltd	3	Marketed
May 22, 2012	NevirapineANDA 203176	Tech Organized	3	Discontinued
May 22, 2012	NevirapineANDA 77702	Aurobindo	6	Marketed
Apr 3, 2014	NevirapineANDA 203411	Sandoz	4	Marketed
Apr 3, 2014	NevirapineANDA 205258	Apotex	0	Discontinued
Oct 27, 2014	NevirapineANDA 205651	Mylan	5	Marketed
Sep 11, 2015	NevirapineANDA 204621	Alvogen	3	Discontinued
Oct 15, 2015	NevirapineANDA 206448	Cipla	5	Discontinued
Nov 9, 2015	NevirapineANDA 206271	Pharmobedient	2	Discontinued
Nov 23, 2016	NevirapineANDA 208616	Aurobindo Pharma	3	Discontinued
Feb 28, 2017	NevirapineANDA 207698	Aurobindo Pharma	3	Discontinued
Jul 31, 2017	NevirapineANDA 207467	Tech Organized	0	Discontinued
Aug 3, 2017	NevirapineANDA 207684	Cipla	1	Marketed
Oct 6, 2017	NevirapineANDA 206879	Macleods Pharms	2	Marketed
Jan 14, 2019	NevirapineANDA 90688	Macleods Pharms	2	Marketed
—	Nevirapine Tablets For Oral SuspensionNDA 22299	Aurobindo Pharma Ltd	0	Discontinued
—	NevirapineANDA 77429	Ranbaxy	0	Discontinued
—	NevirapineANDA 78887	Emcure Pharma	0	Discontinued
—	NevirapineNDA 202212	Cipla Limited	0	Discontinued
—	NevirapineANDA 205921	Mylan Labs Ltd	0	Discontinued
—	NevirapineANDA 207064	Cipla Limited	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA