Orange Book product · Brand (NDA)
EKTERLY
SEBETRALSTAT
At a glance
Jul 03, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 03, 2025
1 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 03, 2030
in 4 yr 1 mo
Exclusivity ends · ODE-534
Orphan-drug exclusivity (7 years)
Jul 03, 2032
in 6 yr 2 mo
Patent 10364238 expires
Listed drug substance patent expiration.
Nov 26, 2035
in 9 yr 7 mo
Patent 10611758 expires
Listed method-of-use patent (U-4223) expiration.
Nov 26, 2035
in 9 yr 7 mo
Patent 11001578 expires
Listed drug substance patent expiration.
Nov 26, 2035
in 9 yr 7 mo
Patent 11084809 expires
Listed drug substance patent expiration.
Nov 26, 2035
in 9 yr 7 mo
Patent 11198691 expires
Listed method-of-use patent (U-4223) expiration.
Nov 26, 2035
in 9 yr 7 mo
Patent 11739068 expires
Listed method-of-use patent (U-4223) expiration.
Jun 23, 2037
in 11 yr 2 mo
Patent 11230537 expires
Listed drug substance patent expiration.
Dec 25, 2037
in 11 yr 8 mo
Patent 11234939 expires
Listed drug product patent expiration.
Jan 26, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
SEBETRALSTAT
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219301
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 (2)
- NCENew chemical entity exclusivity (5 years)
Jul 03, 2030
in 4 yr 1 mo
- ODE-534Orphan-drug exclusivity (7 years)
Jul 03, 2032
in 6 yr 2 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10364238 | Nov 26, 2035 | in 9 yr 7 mo | SubstanceProduct |
| 10611758 | Nov 26, 2035 | in 9 yr 7 mo | U-4223 |
| 11001578 | Nov 26, 2035 | in 9 yr 7 mo | SubstanceProduct |
| 11084809 | Nov 26, 2035 | in 9 yr 7 mo | SubstanceProductU-4223 |
| 11198691 | Nov 26, 2035 | in 9 yr 7 mo | U-4223 |
| 11739068 | Jun 23, 2037 | in 11 yr 2 mo | U-4223 |
| 11230537 | Dec 25, 2037 | in 11 yr 8 mo | SubstanceProduct |
| 11234939 | Jan 26, 2039 | in 12 yr 9 mo | ProductU-4223 |
