FDA Orange Book
Is there a generic for Voranigo?
Voranigo contains vorasidenib. 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 Voranigo (vorasidenib). The Orange Book shows its last listed patent expires January 16, 2039 and its last listed exclusivity ends August 6, 2031.
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Voranigo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 218784, held by SERVIER PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Voranigo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12433895 | July 11, 2034 | Method of use | U-4286 | 218784 |
| 10172864 | July 11, 2034 | Drug substance, Drug product | None | 218784 |
| 9579324 | July 11, 2034 | Drug substance | None | 218784 |
| 11844758 | December 4, 2035 | Method of use | U-3977 | 218784 |
| 11345677 | January 16, 2039 | Drug substance, Drug product | U-3978 | 218784 |
Voranigo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 6, 2029 | 218784 |
| ODE-491 | Orphan drug exclusivity | August 6, 2031 | 218784 |
Voranigo NDC codes
Questions
Is there a generic for Voranigo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Voranigo (vorasidenib). The Orange Book shows its last listed patent expires January 16, 2039 and its last listed exclusivity ends August 6, 2031.
What is the generic name for Voranigo?
The active ingredient in Voranigo is vorasidenib, per the FDA Orange Book.
When does the Voranigo patent expire?
The last patent listed for Voranigo in the Orange Book expires January 16, 2039. 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.