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VIRAMUNE

NDA

NEVIRAPINE | N020933 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

154 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 137 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Early Infant HIV Treatment in Botswana NCT02369406	Phase 2/3	Active	Harvard School of Public Health (HSPH)	67	2015-05-04 → 2029-06-30
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission NCT02140255	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	1,120	2015-01-23 → 2031-12-31
Nevirapine + 3TC Based Maintenance Therapy for HIV Infection NCT03223402	N/A	Completed	Cantonal Hospital of St. Gallen	20	2016-12-23 → 2018-05-31
A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir NCT00001095	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	94	— → 1999-10
Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only NCT00415090	Phase 4	Completed	Hospital de Calella	28	2004-08 → 2006-07
Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products NCT00455585	Phase 4	Completed	Makerere University	18	2007-01 → 2007-11
Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting NCT01772940	Phase 4	Completed	Centre Hospitalier Universitaire Saint Pierre	425	2008-12 → 2011-12
A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine NCT00001688	Phase 2	Completed	National Cancer Institute (NCI)	25	1998-01 → 2001-11
Clinical Trial of Brain-Penetrating HIV Drugs to Prevent Cognitive Impairment in China NCT01340950	Phase 4	Completed	University of California, San Diego	250	2010-07 → 2015-07
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa NCT02028676	Phase 4	Completed	Medical Research Council	1,206	2007-03 → 2012-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain12 active DMFs8 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDNEVIRAPINE

DMF 177822004

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP

DMF 178512004

CIPLA LTDNEVIRAPINE USP

DMF 179052004

MATRIX PHARMACORP PRIVATE LTDNEVIRAPINE USP (ANHYDROUS)

DMF 179152004

APITORIA PHARMA PRIVATE LTDNEVIRAPINE HEMIHYDRATE USP

DMF 184012005

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP

DMF 185762005

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE USP

DMF 197122006

CIPLA LTDNEVIRAPINE HEMIHYDRATE USP

DMF 197532008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDNEVIRAPINE USP

DMF 212802008

APITORIA PHARMA PRIVATE LTDNEVIRAPINE ANHYDROUS USP (PROCESS II)

DMF 245202011

HETERO LABS LTDNEVIRAPINE ANHYDROUS

DMF 246102011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEVIRAPINE HEMIHYDRATE USP

DMF 296062016

MYLAN LABORATORIES LTDInactiveNEVIRAPINE HEMIHYDRATE USP

DMF 193682006

MATRIX LABORATORIES LTDInactiveNEVIRAPINE USP, NON-STERILE BULK FORM

DMF 193792005

RANBAXY LABORATORIES LTDInactiveNEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE

DMF 200882006

ARCH PHARMALABS LTDInactiveNEVIRAPINE ANHYDROUS USP

DMF 221622008

SEQUENT SCIENTIFIC LTDInactiveNEVIRAPINE ANHYDROUS

DMF 231242009

MYLAN LABORATORIES LTDInactiveNEVIRAPINE USP (ANHYDROUS) (RAN)

DMF 233682009

MATRIX PHARMA GROUP XIAMEN LTDInactiveNEVIRAPINE ANHYDROUS USP

DMF 252212011

TYCHE INDUSTRIES LTDInactiveNEVIRAPINE

DMF 281052014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

21 letters from Drugs@FDA

Date	Submission	Document
Jul 23, 2024	SUPPL -48	View Letter (PDF)
Jun 13, 2022	SUPPL -43	View Letter (PDF)
Oct 1, 2018	SUPPL -40	View Letter (PDF)
Mar 29, 2017	SUPPL -38	View Letter (PDF)
Jan 28, 2014	SUPPL -35	View Letter (PDF)
Nov 13, 2012	SUPPL -33	View Letter (PDF)
Nov 14, 2011	SUPPL -30	View Letter (PDF)
May 10, 2011	SUPPL -29	View Letter (PDF)
Mar 31, 2011	SUPPL -28	View Letter (PDF)
Jan 14, 2011	SUPPL -27	View Letter (PDF)
Jul 23, 2010	SUPPL -26	View Letter (PDF)
Jan 26, 2010	SUPPL -22	View Letter (PDF)
Jun 30, 2008	SUPPL -17	View Letter (PDF)
Aug 17, 2007	SUPPL -19	View Letter (PDF)
Apr 20, 2007	SUPPL -15	View Letter (PDF)
Mar 2, 2005	SUPPL -14	View Letter (PDF)
Jun 30, 2004	SUPPL -10	View Letter (PDF)
Jun 30, 2004	SUPPL -6	View Letter (PDF)
Jun 30, 2004	ORIG -1	View Letter (PDF)
Dec 23, 2003	SUPPL -11	View Letter (PDF)
Mar 27, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Sep 11, 1998

No patent or exclusivity listings for this strength.