Orange Book product · Brand (NDA)
REVUFORJ
REVUMENIB CITRATE
At a glance
Nov 15, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 15, 2024
1 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 15, 2029
in 3 yr 6 mo
Exclusivity ends · ODE-502
Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
Exclusivity ends · ODE-504
Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
Exclusivity ends · ODE-505
Orphan-drug exclusivity (7 years)
Nov 15, 2031
in 5 yr 6 mo
Patent 10683302 expires
Listed drug substance patent expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 11479557 expires
Listed drug product patent expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 11479557 expires
Listed drug product patent expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 12564590 expires
Listed drug product patent expiration.
Dec 18, 2042
in 16 yr 9 mo
Patent 12564590 expires
Listed drug product patent expiration.
Dec 18, 2042
in 16 yr 9 mo
Pharmaceutical detail
Active ingredient
REVUMENIB CITRATE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218944
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- 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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10683302 | Jun 08, 2037 | in 11 yr 2 mo | SubstanceProduct |
| 11479557 | Jun 08, 2037 | in 11 yr 2 mo | ProductU-4327 |
| 11479557 | Jun 08, 2037 | in 11 yr 2 mo | ProductU-4045 |
| 12564590 | Dec 18, 2042 | in 16 yr 9 mo | ProductU-4045 |
| 12564590 | Dec 18, 2042 | in 16 yr 9 mo | ProductU-4327 |

