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
25MG/ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 218033
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 |
