Orange Book product · Brand (NDA)
TRUSELTIQ
INFIGRATINIB PHOSPHATE
At a glance
May 28, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2021
5 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
Today
Exclusivity ends · ODE-353
Orphan-drug exclusivity (7 years)
May 28, 2028
in 2 yr
Patent 9067896 expires
Listed drug substance patent expiration.
Aug 06, 2028
in 2 yr 2 mo
Patent 8552002 expires
Listed drug substance patent expiration.
Aug 25, 2029
in 3 yr 3 mo
Patent 10278969 expires
Listed drug product patent expiration.
Dec 11, 2034
in 8 yr 7 mo
Patent 11160804 expires
Listed drug product patent expiration.
Dec 11, 2034
in 8 yr 7 mo
Pharmaceutical detail
Active ingredient
INFIGRATINIB PHOSPHATE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 214622
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
May 28, 2026
22 d ago
- ODE-353Orphan-drug exclusivity (7 years)
May 28, 2028
in 2 yr
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9067896 | Aug 06, 2028 | in 2 yr 2 mo | Substance |
| 8552002 | Aug 25, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 10278969 | Dec 11, 2034 | in 8 yr 7 mo | Product |
| 11160804 | Dec 11, 2034 | in 8 yr 7 mo | Product |
