Orange Book product · Brand (NDA)
EXXUA
GEPIRONE HYDROCHLORIDE
At a glance
Sep 22, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 22, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 22, 2028
in 2 yr 4 mo
Patent 7538116 expires
Listed method-of-use patent (U-3699) expiration.
Sep 02, 2030
in 4 yr 3 mo
Pharmaceutical detail
Active ingredient
GEPIRONE HYDROCHLORIDE
Strength
EQ 18.2MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021164
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)
Sep 22, 2028
in 2 yr 4 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7538116 | Sep 02, 2030 | in 4 yr 3 mo | U-3699 |
