Orange Book product · Brand (NDA)
OJEMDA
TOVORAFENIB
At a glance
Apr 23, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 23, 2024
2 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 23, 2029
in 2 yr 11 mo
Exclusivity ends · ODE-478
Orphan-drug exclusivity (7 years)
Apr 23, 2031
in 4 yr 11 mo
Patent 8293752 expires
Listed drug substance patent expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 10426782 expires
Listed drug product patent expiration.
Jun 23, 2035
in 9 yr 2 mo
Pharmaceutical detail
Active ingredient
TOVORAFENIB
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217700
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
Apr 23, 2029
in 2 yr 11 mo
- ODE-478Orphan-drug exclusivity (7 years)
Apr 23, 2031
in 4 yr 11 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8293752 | Aug 04, 2031 | in 5 yr 2 mo | SubstanceProduct |
| 10426782 | Jun 23, 2035 | in 9 yr 2 mo | Product |
