FDA Orange Book
Is there a generic for Ponvory?
Ponvory contains ponesimod. 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 Ponvory (ponesimod). The Orange Book shows its last listed patent expires December 24, 2044 and its last listed exclusivity ends March 18, 2026.
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Ponvory 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 | 2MG; 3MG; 4MG; 5MG; 6MG; 7MG; 8MG; 9MG; 10MG | Marketed (Rx) | None | 0 | None |
NDA 213498, held by VANDA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ponvory patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE43728 | November 16, 2029 | Drug substance, Drug product | None | 213498 |
| 9062014 | May 6, 2032 | Drug substance, Drug product | U-2774 | 213498 |
| 12336980 | December 10, 2035 | Method of use | U-3103 | 213498 |
| 10220023 | December 10, 2035 | Method of use | U-3103 | 213498 |
| 11951097 | October 10, 2042 | Method of use | U-3891 | 213498 |
| 12728116 | December 24, 2044 | Method of use | U-4610 | 213498 |
Ponvory exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 18, 2026 | 213498 |
Ponvory NDC codes
Questions
Is there a generic for Ponvory?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ponvory (ponesimod). The Orange Book shows its last listed patent expires December 24, 2044 and its last listed exclusivity ends March 18, 2026.
What is the generic name for Ponvory?
The active ingredient in Ponvory is ponesimod, per the FDA Orange Book.
When does the Ponvory patent expire?
The last patent listed for Ponvory in the Orange Book expires December 24, 2044. 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.