FDA Orange Book · active-ingredient family
Istradefylline
Istradefylline is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NOURIANZ · NDA 022075
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOURIANZRLD×2 | KYOWA KIRIN | NDA 022075 | — | Aug 27, 2019 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8318201 | Sep 05, 2027 | in 1 yr 3 mo | Product |
| 7727993 | Jan 28, 2028 | in 1 yr 8 mo | ProductU-2623 |
Istradefylline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
