FDA Orange Book · active-ingredient family
Futibatinib
Futibatinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:LYTGOBI · NDA 214801
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LYTGOBIRLD×2 | TAIHO ONCOLOGY | NDA 214801 | — | Sep 30, 2022 |
Marketing exclusivity (4)
- NCENew chemical entity exclusivity (5 years)
Sep 30, 2027
in 1 yr 4 mo
- ODE-410Orphan-drug exclusivity (7 years)
Sep 30, 2029
in 3 yr 4 mo
- NCENew chemical entity exclusivity (5 years)
Sep 30, 2027
in 1 yr 4 mo
- ODE*FDA marketing exclusivity
Sep 30, 2029
in 3 yr 4 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9108973 | Feb 13, 2033 | in 6 yr 9 mo | SubstanceProductU-3456 |
| 10434103 | Mar 31, 2036 | in 9 yr 11 mo | SubstanceProduct |
| 11833151 | Nov 05, 2039 | in 13 yr 7 mo | Product |
Futibatinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
