FDA Orange Book · active-ingredient family
Revumenib citrate
Revumenib citrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:REVUFORJ · NDA 218944
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
12
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REVUFORJRLD×3 | SYNDAX | NDA 218944 | — | Nov 15, 2024 |
Marketing exclusivity (12)
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2029
in 3 yr 6 mo
- ODE-502Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-504Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-505Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2029
in 3 yr 6 mo
- ODE-502Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-504Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-505Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2029
in 3 yr 6 mo
- ODE-502Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-504Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
- ODE-505Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11479557 | Jun 08, 2037 | in 11 yr 2 mo | ProductU-4327 |
| 10683302 | Jun 08, 2037 | in 11 yr 2 mo | SubstanceProduct |
| 12564590 | Dec 18, 2042 | in 16 yr 9 mo | ProductU-4045 |
Revumenib citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
