FDA Orange Book · active-ingredient family
Tovorafenib
Tovorafenib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OJEMDA · NDA 218033
2
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
4
Exclusivity periods
Brand (NDA) products · for suspension, tablet
Marketing exclusivity (4)
- 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
- 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 |
Tovorafenib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
