Ketoprofen

Sold as Orudis, Oruvail, Orudis Kt, Actron, Nexcede. Every FDA application for this active ingredient: 5 branded and 10 generic.

As of Nov 14, 2026, FDA lists 15 applications for Ketoprofen (sold as Orudis, Oruvail, Orudis Kt and others), first approved Jan 9, 1986, with 2 new uses approved and 0 published complete response letters.

First approved: Jan 9, 1986
Applications: 15
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $2.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Ketoprofen	Part D	$2.3M	+21%	766
Kiprofen	Part D	$18K	New	11

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

KETOPROFEN ER 200 MG CAPSULE: $6.46 per unitGeneric · +14% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

MohrusDrugs with new additional indications for the treatment of myalgia and post-traumatic swelling/pain. · Hisamitsu Pharmaceutical Co., Inc. · Feb 23, 2011
MohrusDrugs with a new additional indication for relief of local pain associated with rheumatoid arthritis. · Hisamitsu Pharmaceutical Co., Inc. · Nov 6, 2009

Clinical Trials

12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal SurgeryMultimodal Analgesia, Tramadol · Centre Hospitalier Universitaire, Amiens	Not applicable	Recruiting	Nov 3, 2026
TAP vs. ESP Blocks for Post-Cesarean AnalgesiaPostoperative Pain After Cesarean Section · Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog	Not applicable	Not yet recruiting	Oct 1, 2026
Adaptive Platform Trial for Pain Management in Sickle Cell Vaso-Occlusive CrisisSickle Cell Disease, Vaso-occlusive Crisis · Assistance Publique - Hôpitaux de Paris	Phase 4	Not yet recruiting	Sep 18, 2026
Combined Distal Femoral Nerve Block for Pain Control After Knee ReplacementPain After Total Knee Arthroplasty, Pain Management · GCS Ramsay Santé pour l'Enseignement et la Recherche	Not applicable	Recruiting	Jun 5, 2026
Novel Transdermal Ketoprofen Gel Formulation for Knee OsteoarthritisKnee Osteoarthritis · New Valley University	Phase 1	Active, not recruiting	Jan 6, 2026
Reducing Chronic Pain After Lung Surgery: A Trial of Limiting NSAIDs During RecoveryChronic Post-operative Pain · University Hospital, Strasbourg, France	Phase 3	Not yet recruiting	Aug 7, 2025
Multiprofen-CC to Reduce Pain in Hand ArthritisHand Osteoarthritis · St. Joseph's Healthcare Hamilton	Phase 3	Recruiting	May 11, 2025
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)Fibrosis Syndrome, Lymphedema · M.D. Anderson Cancer Center	Phase 2	Recruiting	Apr 6, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 9, 1986	OrudisNDA 18754 · New molecular entity	Wyeth Ayerst	22	Discontinued
Dec 22, 1992	KetoprofenANDA 73515	Teva	10	Discontinued
Dec 22, 1992	KetoprofenANDA 73516	Teva	19	Marketed
Dec 22, 1992	KetoprofenANDA 73517	Teva	18	Discontinued
Jan 29, 1993	KetoprofenANDA 74014	Misemer	10	Marketed
Sep 24, 1993	OruvailNDA 19816 · New dosage form	Wyeth Pharms Inc	10	Discontinued
Oct 6, 1995	Orudis KtNDA 20429 · New dosage form	Wyeth Cons	7	Discontinued
Oct 6, 1995	ActronNDA 20499 · New dosage form	Bayer	2	Discontinued
Dec 29, 1995	KetoprofenANDA 74024	Rising	4	Discontinued
Dec 31, 1996	KetoprofenANDA 74035	Rising	9	Discontinued
Dec 10, 1997	KetoprofenANDA 74879	Alkermes Gainesville	4	Discontinued
Mar 24, 1999	KetoprofenANDA 75270	Actavis Labs Fl Inc	9	Discontinued
Feb 7, 2002	KetoprofenANDA 75364	Perrigo	0	Discontinued
Feb 20, 2002	KetoprofenANDA 75679	Mylan	5	Marketed
Nov 25, 2009	NexcedeNDA 22470 · New dosage form	Novartis	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA