Orange Book product · Brand (NDA)
FOTIVDA
TIVOZANIB HYDROCHLORIDE
At a glance
Mar 10, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 10, 2021
5 yr 4 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 10, 2026
3 mo ago
Today
Patent 7166722 expires
Listed drug substance patent expiration.
Nov 16, 2028
in 2 yr 5 mo
Patent 11504365 expires
Listed method-of-use patent (U-3476) expiration.
Nov 05, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
TIVOZANIB HYDROCHLORIDE
Strength
EQ 0.89MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212904
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)
Mar 10, 2026
3 mo ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7166722 | Nov 16, 2028 | in 2 yr 5 mo | SubstanceProduct |
| 11504365 | Nov 05, 2039 | in 13 yr 7 mo | U-3476 |
