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VIRAMUNE

NDA

NEVIRAPINE | N020636 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. et al v. Mylan Inc. et al 1:2014cv03928 3 patentsANDA 020636emtricitabine and tenofovir disoproxil fumarate	S.D.N.Y.	2014-06-02	Terminated 2014-06-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nevirapine ER (2023)

Total Spending

$2.2M

Total Claims

6,709

Beneficiaries

897

Avg Cost/Unit

$7.83

Spending Trend

$1.9M(2019)→$2.8M(2020)→$2.8M(2021)→$2.5M(2022)→$2.2M(2023)

YoY Change:-5.7%

5yr CAGR:-3.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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
Jun 13, 2022	SUPPL -52	View Letter (PDF)
Oct 1, 2018	SUPPL -50	View Letter (PDF)
Mar 29, 2017	SUPPL -48	View Letter (PDF)
Jan 28, 2014	SUPPL -44	View Letter (PDF)
Nov 13, 2012	SUPPL -42	View Letter (PDF)
Nov 14, 2011	SUPPL -39	View Letter (PDF)
May 10, 2011	SUPPL -38	View Letter (PDF)
Mar 31, 2011	SUPPL -37	View Letter (PDF)
Jan 14, 2011	SUPPL -36	View Letter (PDF)
Jul 23, 2010	SUPPL -35	View Letter (PDF)
Jan 26, 2010	SUPPL -32	View Letter (PDF)
Jun 30, 2008	SUPPL -27	View Letter (PDF)
Aug 17, 2007	SUPPL -29	View Letter (PDF)
Apr 20, 2007	SUPPL -26	View Letter (PDF)
Mar 2, 2005	SUPPL -25	View Letter (PDF)
Jun 30, 2004	SUPPL -16	View Letter (PDF)
Jun 30, 2004	SUPPL -9	View Letter (PDF)
May 26, 2004	SUPPL -22	View Letter (PDF)
Dec 23, 2003	SUPPL -21	View Letter (PDF)
Aug 6, 2003	SUPPL -20	View Letter (PDF)
Mar 27, 2002	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 21, 1996

No patent or exclusivity listings for this strength.