FDA Orange Book
Is there a generic for Revuforj?
Revuforj contains revumenib. 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 Revuforj (revumenib). The Orange Book shows its last listed patent expires December 18, 2042 and its last listed exclusivity ends November 15, 2031.
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Revuforj products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 110MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 160MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218944, held by SYNDAX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Revuforj patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11479557 | June 8, 2037 | Drug product | U-4327 | 218944 |
| 11479557 | June 8, 2037 | Drug product | U-4045 | 218944 |
| 10683302 | June 8, 2037 | Drug substance, Drug product | None | 218944 |
| 12564590 | December 18, 2042 | Drug product | U-4045 | 218944 |
| 12564590 | December 18, 2042 | Drug product | U-4327 | 218944 |
Revuforj exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 15, 2029 | 218944 |
| ODE-502 | Orphan drug exclusivity | November 15, 2031 | 218944 |
| ODE-504 | Orphan drug exclusivity | November 15, 2031 | 218944 |
| ODE-505 | Orphan drug exclusivity | November 15, 2031 | 218944 |
Revuforj NDC codes
Questions
Is there a generic for Revuforj?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Revuforj (revumenib). The Orange Book shows its last listed patent expires December 18, 2042 and its last listed exclusivity ends November 15, 2031.
What is the generic name for Revuforj?
The active ingredient in Revuforj is revumenib, per the FDA Orange Book.
When does the Revuforj patent expire?
The last patent listed for Revuforj in the Orange Book expires December 18, 2042. 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.