Orange Book product · Brand (NDA)
ZURZUVAE
ZURANOLONE
At a glance
Oct 31, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2023
2 yr 8 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 31, 2028
in 2 yr 5 mo
Patent 10172871 expires
Listed method-of-use patent (U-2552) expiration.
Apr 17, 2034
in 7 yr 11 mo
Patent 10342810 expires
Listed method-of-use patent (U-2552) expiration.
Apr 17, 2034
in 7 yr 11 mo
Patent 9512165 expires
Listed drug substance patent expiration.
Apr 17, 2034
in 7 yr 11 mo
Patent 11236121 expires
Listed drug substance patent expiration.
Aug 23, 2037
in 11 yr 4 mo
Patent 11884696 expires
Listed method-of-use patent (U-2552) expiration.
Aug 23, 2037
in 11 yr 4 mo
Pharmaceutical detail
Active ingredient
ZURANOLONE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 217369
Product number
002
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)
Oct 31, 2028
in 2 yr 5 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10172871 | Apr 17, 2034 | in 7 yr 11 mo | U-2552 |
| 10342810 | Apr 17, 2034 | in 7 yr 11 mo | U-2552 |
| 9512165 | Apr 17, 2034 | in 7 yr 11 mo | SubstanceProduct |
| 11236121 | Aug 23, 2037 | in 11 yr 4 mo | Substance |
| 11884696 | Aug 23, 2037 | in 11 yr 4 mo | U-2552 |
