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SUSTIVA

NDA

EFAVIRENZ | N021360 | BRISTOL MYERS SQUIBB CO

2 strengths0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK, SHARP & DOHME CORP. et al v. HETERO USA INC. et al 2:2015cv08099 2 patentsANDA 078886Efavirenz	D.N.J.	2015-11-16	Terminated 2016-01-11	—
Merck, Sharp & Dohme Corp. et al v. Teva Pharmaceuticals USA, Inc. et al 1:2010cv01851 2 patentsANDA 091215efavirenz	S.D.N.Y.	2010-03-09	Terminated 2013-06-05	—

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

API Supply Chain18 active DMFs10 inactive

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

APITORIA PHARMA PRIVATE LTDEFAVIRENZ USP

DMF 178022004

MATRIX PHARMACORP PRIVATE LTDEFAVIRENZ USP

DMF 182302005

APITORIA PHARMA PRIVATE LTDEFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE)

DMF 199322006

HETERO LABS LTDEFAVIRENZ (PROCESS I)

DMF 200152006

CIPLA LTDEFAVIRENZ USP

DMF 207112008

MACLEODS PHARMACEUTICALS LTDEFAVIRENZ

DMF 216662008

LAURUS LABS LTDEFAVIRENZ USP

DMF 219642008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDEFAVIRENZ USP

DMF 232712009

CDYMAX (INDIA) PHARMA PRIVATE LTDEFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)]

DMF 248472011

HETERO LABS LTDEFAVIRENZ (PROCESS II)

DMF 249432011

HETERO LABS LTDEFAVIRENZ(FORM-H1)

DMF 250282011

MATRIX PHARMACORP PRIVATE LTDEFAVIRENZ USP (PROCESS - II)

DMF 251902011

HETERO LABS LTDEFAVIRENZ (PROCESS III) USP

DMF 252622011

LAURUS LABS LTDEFAVIRENZ USP (PROCESS-2)

DMF 262422012

MATRIX PHARMACORP PRIVATE LTDEFAVIRENZ USP (PROCESS-IV)

DMF 296142015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDEFAVIRENZ USP

DMF 309592016

ARENE LIFE SCIENCES PRIVATE LTDEFAVIRENZ USP

DMF 338542019

SMS PHARMACEUTICALS LTDEFAVIRENZ USP

DMF 343562021

EMCURE PHARMACEUTICALS LTDInactiveEFAVIRENZ USP

DMF 201962007

RANBAXY LABORATORIES LTDInactiveEFAVIRENZ

DMF 205602007

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveEFAVIRENZ

DMF 217082008

MYLAN LABORATORIES LTDInactiveEFAVIRENZ USP

DMF 219692008

EMCURE PHARMACEUTICALS LTDInactiveEFAVIRENZ (ALTERNATE PROCESS)

DMF 227042009

SEQUENT SCIENTIFIC LTDInactiveEFAVIRENZ

DMF 227082009

LUPIN LTDInactiveEFAVIRENZ USP

DMF 250032011

MYLAN LABORATORIES LTDInactiveEFAVIRENZ USP (PROCESS-III)

DMF 274542013

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveEFAVIRENZ

DMF 314002017

ARENE LIFESCIENCES LTDInactiveEFAVIRENZ USP

DMF 321882017

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

Approval Letters

28 letters from Drugs@FDA

Date	Submission	Document
Nov 13, 2023	SUPPL -47	View Letter (PDF)
Oct 30, 2019	SUPPL -45	View Letter (PDF)
Oct 12, 2017	SUPPL -44	View Letter (PDF)
Jan 31, 2017	SUPPL -42	View Letter (PDF)
Aug 31, 2016	SUPPL -39	View Letter (PDF)
Apr 1, 2016	SUPPL -38	View Letter (PDF)
Apr 1, 2015	SUPPL -37	View Letter (PDF)
May 27, 2014	SUPPL -35	View Letter (PDF)
May 7, 2013	SUPPL -31	View Letter (PDF)
Aug 15, 2012	SUPPL -30	View Letter (PDF)
Jun 26, 2012	SUPPL -29	View Letter (PDF)
Dec 21, 2011	SUPPL -28	View Letter (PDF)
Sep 29, 2011	SUPPL -26	View Letter (PDF)
Dec 3, 2010	SUPPL -24	View Letter (PDF)
Apr 5, 2010	SUPPL -23	View Letter (PDF)
Nov 10, 2009	SUPPL -21	View Letter (PDF)
Mar 12, 2009	SUPPL -18	View Letter (PDF)
Aug 20, 2008	SUPPL -17	View Letter (PDF)
Feb 5, 2007	SUPPL -14	View Letter (PDF)
Feb 2, 2007	SUPPL -16	View Letter (PDF)
Apr 28, 2005	SUPPL -13	View Letter (PDF)
Oct 29, 2004	SUPPL -9	View Letter (PDF)
Aug 25, 2004	SUPPL -6	View Letter (PDF)
Nov 26, 2003	SUPPL -5	View Letter (PDF)
Jun 22, 2003	SUPPL -4	View Letter (PDF)
Jun 22, 2003	SUPPL -3	View Letter (PDF)
Sep 20, 2002	SUPPL -1	View Letter (PDF)
Feb 1, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 1, 2002

No patent or exclusivity listings for this strength.

#002 — 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 1, 2002