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EFAVIRENZ

ANDA

EFAVIRENZ | A078886 | HETERO LABS LTD UNIT III

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case 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	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 4, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 27, 2018

No patent or exclusivity listings for this strength.