Orange Book product · Brand (NDA)
ZTALMY
GANAXOLONE
At a glance
Jun 01, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 01, 2022
4 yr 1 mo ago
Today
Patent 7858609 expires
Listed drug product patent expiration.
Nov 28, 2026
in 5 mo
Patent 8022054 expires
Listed drug product patent expiration.
Nov 28, 2026
in 5 mo
Patent 8367651 expires
Listed drug product patent expiration.
Nov 28, 2026
in 5 mo
Patent 8618087 expires
Listed method-of-use patent (U-3374) expiration.
Nov 28, 2026
in 5 mo
Patent 9029355 expires
Listed drug product patent expiration.
Nov 28, 2026
in 5 mo
Patent 9056116 expires
Listed method-of-use patent (U-3374) expiration.
Nov 28, 2026
in 5 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 01, 2027
in 1 yr
Exclusivity ends · D-197
New indication / change exclusivity (3 years)
Oct 16, 2028
in 2 yr 4 mo
Exclusivity ends · ODE-395
Orphan-drug exclusivity (7 years)
Jun 01, 2029
in 3 yr
Patent 8318714 expires
Listed drug product patent expiration.
Nov 28, 2031
in 5 yr 6 mo
Patent 10603308 expires
Listed method-of-use patent (U-3374) expiration.
Aug 10, 2037
in 11 yr 4 mo
Patent 12144801 expires
Listed method-of-use patent (U-4034) expiration.
Aug 10, 2037
in 11 yr 4 mo
Patent 12115169 expires
Listed method-of-use patent (U-3374) expiration.
Sep 30, 2042
in 16 yr 6 mo
Patent 12268696 expires
Listed method-of-use patent (U-3374) expiration.
Sep 30, 2042
in 16 yr 6 mo
Pharmaceutical detail
Active ingredient
GANAXOLONE
Strength
50MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 215904
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 (3)
- NCENew chemical entity exclusivity (5 years)
Jun 01, 2027
in 1 yr
- D-197New indication / change exclusivity (3 years)
Oct 16, 2028
in 2 yr 4 mo
- ODE-395Orphan-drug exclusivity (7 years)
Jun 01, 2029
in 3 yr
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7858609 | Nov 28, 2026 | in 5 mo | Product |
| 8022054 | Nov 28, 2026 | in 5 mo | Product |
| 8367651 | Nov 28, 2026 | in 5 mo | Product |
| 8618087 | Nov 28, 2026 | in 5 mo | U-3374 |
| 9029355 | Nov 28, 2026 | in 5 mo | Product |
| 9056116 | Nov 28, 2026 | in 5 mo | U-3374 |
| 8318714 | Nov 28, 2031 | in 5 yr 6 mo | Product |
| 10603308 | Aug 10, 2037 | in 11 yr 4 mo | U-3374 |
| 12144801 | Aug 10, 2037 | in 11 yr 4 mo | U-4034 |
| 12115169 | Sep 30, 2042 | in 16 yr 6 mo | U-3374 |
| 12268696 | Sep 30, 2042 | in 16 yr 6 mo | U-3374 |
