FDA Orange Book
Is there a generic for Winlevi?
Winlevi contains clascoterone. 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 Winlevi (clascoterone). The Orange Book shows its last listed patent expires August 26, 2031.
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Winlevi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 213433, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Winlevi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12337002 | July 24, 2028 | Drug product | U-3280 | 213433 |
| 9486458 | July 24, 2028 | Method of use | U-2942 | 213433 |
| 11938141 | July 24, 2028 | Drug product | None | 213433 |
| 10159682 | August 14, 2028 | Method of use | U-2942 | 213433 |
| 11207332 | November 20, 2028 | Drug product | U-3280 | 213433 |
| 8785427 | July 25, 2030 | Drug product | None | 213433 |
| 9433628 | August 26, 2031 | Drug substance, Drug product | None | 213433 |
Winlevi NDC codes
Questions
Is there a generic for Winlevi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Winlevi (clascoterone). The Orange Book shows its last listed patent expires August 26, 2031.
What is the generic name for Winlevi?
The active ingredient in Winlevi is clascoterone, per the FDA Orange Book.
When does the Winlevi patent expire?
The last patent listed for Winlevi in the Orange Book expires August 26, 2031. 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.