Orange Book product · Brand (NDA)
VEOZAH
FEZOLINETANT
At a glance
May 12, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 12, 2023
3 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 12, 2028
in 1 yr 11 mo
Patent 8871761 expires
Listed drug substance patent expiration.
Apr 04, 2031
in 4 yr 10 mo
Patent 10836768 expires
Listed method-of-use patent (U-3622) expiration.
Mar 28, 2034
in 7 yr 11 mo
Patent 9422299 expires
Listed drug substance patent expiration.
Mar 28, 2034
in 7 yr 11 mo
Patent 9987274 expires
Listed method-of-use patent (U-3622) expiration.
Mar 28, 2034
in 7 yr 11 mo
Pharmaceutical detail
Active ingredient
FEZOLINETANT
Strength
45MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216578
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 (1)
- NCENew chemical entity exclusivity (5 years)
May 12, 2028
in 1 yr 11 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8871761 | Apr 04, 2031 | in 4 yr 10 mo | Substance |
| 10836768 | Mar 28, 2034 | in 7 yr 11 mo | U-3622 |
| 9422299 | Mar 28, 2034 | in 7 yr 11 mo | SubstanceProductU-3622 |
| 9987274 | Mar 28, 2034 | in 7 yr 11 mo | U-3622 |
