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NDA

KETOPROFEN | N019816 | WYETH PHARMACEUTICALS INC

3 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs18 inactive

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

SIMS SRLKETOPROFEN

DMF 69971987

COSMA SPAKETOPROFEN

DMF 75991988

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLKETOPROFEN

DMF 194572006

EUROAPI GERMANY GMBHKETOPROFEN

DMF 236002010

SOLARA ACTIVE PHARMA SCIENCES LTDKETOPROFEN USP

DMF 241792010

SCL LIFESCIENCES LTDKETOPROFEN USP

DMF 365272024

SNJ LIFECARE PVT LTDKETOPROFEN USP

DMF 402262024

SANOFI CHIMIEInactiveKETOPROFEN (19,583 R.P.)

DMF 36051979

KV PHARMACEUTICAL COInactiveKETOPROFEN S.R. CAPS., 150MG & 200MG

DMF 43981981

TEMMLER WERKE VEREINIGTE CHEMISCHE FABRIKENInactiveKETOPROFEN CR CAPSULES 200&300MG, MNFG IN MARBURG,WEST GERMANY

DMF 48751983

TEMMLER WERKE VEREINIGTE CHEMISCHE FABRIKENInactiveKETOPROFEN S.R. CAPSULES

DMF 54551984

MAY AND BAKER LTDInactiveKETOPROFEN

DMF 67361986

SUMIKA FINE CHEMICALS CO LTDInactiveKETOPROFEN

DMF 79061989

SIBEFAT SPAInactiveKETOPROFEN

DMF 79981989

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveKETOPROFEN

DMF 82001989

MEDICHEM SAInactiveKETOPROFEN

DMF 82851989

NOBEL CHEMS SPAInactiveKETOPROFEN

DMF 83521989

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTDInactiveKETOPROFEN USP XXII

DMF 84161990

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveKETOPROFEN

DMF 85511990

KERFOOT PHARMACEUTICALSInactiveKETOPROFEN

DMF 90991991

NORDIC SYNTHESIS ABInactiveKETOPROFEN

DMF 100451993

CHIREX LTDInactiveKETOPROFEN

DMF 120201996

BIDACHEM SPAInactiveKETOPROFEN

DMF 181482005

HUBEI XUNDA PHARMACEUTICAL CO LTDInactiveKETOPROFEN

DMF 221492008

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveKETOPROFEN

DMF 236362010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2007	SUPPL -11	View Letter (PDF)
Jan 20, 2006	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Sep 24, 1993

No patent or exclusivity listings for this strength.

#002 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 8, 1995

#003 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 8, 1995