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ORUDIS

NDA

KETOPROFEN | N018754 | WYETH AYERST LABORATORIES

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Camargo Pharmaceutical Services, LLC FDA-2006-P-0083 · 5 docket documents Camargo Pharmaceutical Services, LLC filed a citizen petition requesting that the FDA reconsider the regulatory status of ketoprofen, specifically addressing the over-the-counter formulation Orudis KT and its safety profile relative to other nonsteroidal anti-inflammatory drugs, with supporting evid	Other	2009-03-25	Open	Camargo Pharmaceutical Services, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

64 trials from ClinicalTrials.gov, 51 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic NCT00553605	Phase 4	Completed	Pfizer	340	2007-06 → 2009-06
Intravenous Paracetamol for Postoperative Pain NCT02248493	Phase 4	Completed	Lithuanian University of Health Sciences	54	2012-11 → 2017-03
Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery NCT02238340	Phase 4	Completed	Hospital Central Dr. Luis Ortega	40	2012-03 → 2012-09
A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee NCT00903994	Phase 2	Completed	APR Applied Pharma Research s.a.	17	2007-06 → 2007-08
Topical Intra-Oral Ketoprofen for Migraine Prevention NCT01211795	Phase 3	Completed	Behar, Caren, M.D.	67	2009-10 → 2011-06
Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise NCT01020279	Phase 1	Completed	X-pert Med GmbH	82	2009-10 → 2010-01
Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal NCT02730026	Phase 4	Completed	Luis Fernando Simoneti	50	2015-06 → 2017-03
Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain NCT02393846	Phase 4	Completed	Akdeniz University	100	2015-02 → 2015-06
Crossover, Single Dose Randomized, Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Oral Solution NCT02350296	Phase 1	Completed	Dompé Farmaceutici S.p.A	30	2014-11-26 → 2015-04-22
Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole NCT00971581	Phase 3	Completed	Sanofi	52	2009-08 → 2010-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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
Jan 20, 2006	SUPPL -27	View Letter (PDF)
Aug 26, 2003	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 31, 1987

No patent or exclusivity listings for this strength.

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 9, 1986

#003 — 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 9, 1986