Orange Book product · Brand (NDA)
VORANIGO
VORASIDENIB
At a glance
Aug 06, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 06, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 06, 2029
in 3 yr 2 mo
Exclusivity ends · ODE-491
Orphan-drug exclusivity (7 years)
Aug 06, 2031
in 5 yr 2 mo
Patent 10172864 expires
Listed drug substance patent expiration.
Jul 11, 2034
in 8 yr 2 mo
Patent 12433895 expires
Listed method-of-use patent (U-4286) expiration.
Jul 11, 2034
in 8 yr 2 mo
Patent 9579324 expires
Listed drug substance patent expiration.
Jul 11, 2034
in 8 yr 2 mo
Patent 11844758 expires
Listed method-of-use patent (U-3977) expiration.
Dec 04, 2035
in 9 yr 7 mo
Patent 11345677 expires
Listed drug substance patent expiration.
Jan 16, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
VORASIDENIB
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218784
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 (2)
- NCENew chemical entity exclusivity (5 years)
Aug 06, 2029
in 3 yr 2 mo
- ODE-491Orphan-drug exclusivity (7 years)
Aug 06, 2031
in 5 yr 2 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10172864 | Jul 11, 2034 | in 8 yr 2 mo | SubstanceProduct |
| 12433895 | Jul 11, 2034 | in 8 yr 2 mo | U-4286 |
| 9579324 | Jul 11, 2034 | in 8 yr 2 mo | Substance |
| 11844758 | Dec 04, 2035 | in 9 yr 7 mo | U-3977 |
| 11345677 | Jan 16, 2039 | in 12 yr 9 mo | SubstanceProductU-3978 |
