FDA Orange Book · active-ingredient family
Ketoprofen
Ketoprofen is approved as 5 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ORUDIS KT · NDA 020429
5
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, film, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORUDIS KTRLD | WYETH CONS | NDA 020429 | — | Oct 06, 1995 | |
| ORUVAILRLD×3 | WYETH PHARMS INC | NDA 019816 | — | Feb 08, 1995 | |
| ORUDISRLD×3 | WYETH AYERST | NDA 018754 | — | Jul 31, 1987 | |
| NEXCEDE | NOVARTIS | NDA 022470 | — | Nov 25, 2009 | |
| ACTRON | BAYER | NDA 020499 | — | Oct 06, 1995 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KETOPROFEN×3 | MYLAN | ANDA 075679 | — | Feb 20, 2002 | |
| KETOPROFEN | PERRIGO | ANDA 075364 | — | Feb 07, 2002 | |
| KETOPROFEN×3 | ACTAVIS LABS FL INC | ANDA 075270 | — | Mar 24, 1999 | |
| KETOPROFEN | ALKERMES GAINESVILLE | ANDA 074879 | — | Dec 10, 1997 | |
| KETOPROFEN×2 | RISING | ANDA 074035 | — | Dec 31, 1996 | |
| KETOPROFEN×2 | RISING | ANDA 074024 | — | Dec 29, 1995 | |
| KETOPROFEN×3 | MISEMER | ANDA 074014 | — | Jan 29, 1993 | |
| KETOPROFEN | TEVA | ANDA 073515 | — | Dec 22, 1992 | |
| KETOPROFEN | TEVA | ANDA 073516 | AB | Dec 22, 1992 | |
| KETOPROFEN | TEVA | ANDA 073517 | — | Dec 22, 1992 |
Listed patents
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.
Ketoprofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
