Orange Book product · Brand (NDA)
ZAVZPRET
ZAVEGEPANT HYDROCHLORIDE
At a glance
Mar 09, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 09, 2023
3 yr 4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 09, 2028
in 1 yr 9 mo
Patent 8481546 expires
Listed drug substance patent expiration.
Jun 26, 2034
in 8 yr 2 mo
Pharmaceutical detail
Active ingredient
ZAVEGEPANT HYDROCHLORIDE
Strength
EQ 10MG BASE/SPRAY
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 216386
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)
Mar 09, 2028
in 1 yr 9 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8481546 | Jun 26, 2034 | in 8 yr 2 mo | SubstanceProductU-3555 |
