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DUTASTERIDE

ANDA

DUTASTERIDE | A204292 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GlaxoSmithKline LLC v. Apotex Inc. 1:2012cv01090 1 patentANDA 204292dutasteride	D. Del.	2012-08-31	Terminated 2014-04-09	—

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

API Supply Chain9 active DMFs8 inactive

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

STERLING SPADUTASTERIDE

DMF 209182007

MSN LABORATORIES PRIVATE LTDDUTASTERIDE USP [ROUTE CODE - "DT"]

DMF 235332010

DR REDDYS LABORATORIES LTDDUTASTERIDE (PROCESS-II) USP

DMF 264752012

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDUTASTERIDE

DMF 268032013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDUTASTERIDE ACID

DMF 277632013

HETERO LABS LTDDUTASTERIDE

DMF 277742013

APITORIA PHARMA PRIVATE LTDDUTASTERIDE USP

DMF 295772015

STERLING CHEMICAL MALTA LTDDUTASTERIDE FORM I

DMF 301432015

MSN LABORATORIES PRIVATE LTDDUTASTERIDE USP

DMF 330632018

CATALENT FRANCE BEINHEIM SAInactiveDUTASTERIDE SOFT GELATIN CAPSULES .5MG

DMF 146431999

DR REDDYS LABORATORIES LTDInactiveDUTASTERIDE (Process-I)

DMF 184082005

CIPLA LTDInactiveDUTASTERIDE

DMF 201802009

FIS FABBRICA ITALIANA SINTETICI SPAInactiveDUTASTERIDE

DMF 234942010

GADOR SAInactiveDUTASTERIDE

DMF 238102010

CATALENT PHARMA SOLUTIONS LLCInactiveDUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES

DMF 243042010

RELIANCE LIFE SCIENCES PVT LTDInactiveDUTASTERIDE

DMF 248802011

IND SWIFT LABORATORIES LTDInactiveDUTASTERIDE USP

DMF 277882014

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

Products (1)

#001 — 0.5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 24, 2015

No patent or exclusivity listings for this strength.