FDA Orange Book
Is there a generic for Veozah?
Veozah contains fezolinetant. 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 Veozah (fezolinetant). The Orange Book shows its last listed patent expires March 28, 2034 and its last listed exclusivity ends May 12, 2028.
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Veozah products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 45MG | Marketed (Rx) | None | 0 | None |
NDA 216578, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Veozah patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8871761 | April 4, 2031 | Drug substance | None | 216578 |
| 10836768 | March 28, 2034 | Method of use | U-3622 | 216578 |
| 9987274 | March 28, 2034 | Method of use | U-3622 | 216578 |
| 9422299 | March 28, 2034 | Drug substance, Drug product | U-3622 | 216578 |
Veozah exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 12, 2028 | 216578 |
Veozah NDC codes
Questions
Is there a generic for Veozah?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Veozah (fezolinetant). The Orange Book shows its last listed patent expires March 28, 2034 and its last listed exclusivity ends May 12, 2028.
What is the generic name for Veozah?
The active ingredient in Veozah is fezolinetant, per the FDA Orange Book.
When does the Veozah patent expire?
The last patent listed for Veozah in the Orange Book expires March 28, 2034. 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.