Orange Book product · Brand (NDA)
LYTGOBI
FUTIBATINIB
At a glance
Sep 30, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 2022
3 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 30, 2027
in 1 yr 4 mo
Exclusivity ends · ODE-410
Orphan-drug exclusivity (7 years)
Sep 30, 2029
in 3 yr 4 mo
Patent 9108973 expires
Listed drug substance patent expiration.
Feb 13, 2033
in 6 yr 9 mo
Patent 10434103 expires
Listed drug substance patent expiration.
Mar 31, 2036
in 9 yr 11 mo
Patent 11833151 expires
Listed drug product patent expiration.
Nov 05, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
FUTIBATINIB
Strength
4MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214801
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)
Sep 30, 2027
in 1 yr 4 mo
- ODE-410Orphan-drug exclusivity (7 years)
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 |
