FDA Orange Book
Is there a generic for Nourianz?
Nourianz contains istradefylline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nourianz (istradefylline). The Orange Book shows its last listed patent expires January 28, 2028.
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Nourianz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 022075, held by KYOWA KIRIN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nourianz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8318201 | September 5, 2027 | Drug product | None | 022075 |
| 7727993 | January 28, 2028 | Drug product | U-2623 | 022075 |
Nourianz NDC codes
Questions
Is there a generic for Nourianz?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nourianz (istradefylline). The Orange Book shows its last listed patent expires January 28, 2028.
What is the generic name for Nourianz?
The active ingredient in Nourianz is istradefylline, per the FDA Orange Book.
When does the Nourianz patent expire?
The last patent listed for Nourianz in the Orange Book expires January 28, 2028. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.