Orange Book product · Brand (NDA)
FRUZAQLA
FRUQUINTINIB
At a glance
Nov 08, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2023
2 yr 8 mo ago
Today
Patent 8212033 expires
Listed method-of-use patent (U-3753) expiration.
May 09, 2028
in 1 yr 11 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 08, 2028
in 2 yr 5 mo
Patent 7829574 expires
Listed drug substance patent expiration.
Mar 23, 2032
in 5 yr 10 mo
Patent 10519142 expires
Listed drug substance patent expiration.
Sep 07, 2035
in 9 yr 4 mo
Patent 11046674 expires
Listed method-of-use patent (U-3753) expiration.
Sep 07, 2035
in 9 yr 4 mo
Pharmaceutical detail
Active ingredient
FRUQUINTINIB
Strength
1MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 217564
Product number
001
Marketing status
RX
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 (1)
- NCENew chemical entity exclusivity (5 years)
Nov 08, 2028
in 2 yr 5 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8212033 | May 09, 2028 | in 1 yr 11 mo | U-3753 |
| 7829574 | Mar 23, 2032 | in 5 yr 10 mo | SubstanceProduct |
| 10519142 | Sep 07, 2035 | in 9 yr 4 mo | SubstanceProductU-3753 |
| 11046674 | Sep 07, 2035 | in 9 yr 4 mo | U-3753 |
