FDA Orange Book · active-ingredient family
Ketoprofen
Ketoprofen: 5 brands, 10 generics; first approved Jan 09, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
10
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- ORUDIS KTRLDWYETH CONSNDA 0204291995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - ORUVAILRLDWYETH PHARMS INCNDA 01981619953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - ORUDISRLDWYETH AYERSTNDA 01875419873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — - NOVARTISNDA 0224702009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG FILM ORAL Discontinued — - BAYERNDA 0204991995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- KETOPROFENMYLANANDA 07567920023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Rx — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - KETOPROFENPERRIGOANDA 0753642002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — - KETOPROFENACTAVIS LABS FL INCANDA 07527019993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 100MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - KETOPROFENALKERMES GAINESVILLEANDA 0748791997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - KETOPROFENRISINGANDA 07403519962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — - KETOPROFENRISINGANDA 07402419952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — - KETOPROFENMISEMERANDA 07401419933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx — 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx — - KETOPROFENTEVAANDA 0735151992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — - KETOPROFENTEVAANDA 0735161992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB - KETOPROFENTEVAANDA 0735171992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
41 yr 4 mo ago
Most recent approval
17 yr 1 mo ago
Approvals span 1986–2009 across 15 FDA applications.
Brand (NDA) 533%
Generic (ANDA) 1067%
Ketoprofen: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
