Orange Book product · Brand (NDA)
SEPHIENCE
SEPIAPTERIN
At a glance
Jul 28, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 2025
11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 28, 2030
in 4 yr 2 mo
Exclusivity ends · ODE-542
Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
Patent 11072614 expires
Listed drug substance patent expiration.
Apr 16, 2038
in 12 yr
Patent 11752154 expires
Listed drug product patent expiration.
Sep 04, 2038
in 12 yr 5 mo
Patent 12213982 expires
Listed method-of-use patent (U-4251) expiration.
Sep 04, 2038
in 12 yr 5 mo
Patent 12257252 expires
Listed method-of-use patent (U-4250) expiration.
Mar 06, 2042
in 15 yr 11 mo
Pharmaceutical detail
Active ingredient
SEPIAPTERIN
Strength
250MG/PACKET
Dosage form
POWDER
Route
ORAL
TE code
Not listed
Application
NDA 219666
Product number
001
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 (2)
- NCENew chemical entity exclusivity (5 years)
Jul 28, 2030
in 4 yr 2 mo
- ODE-542Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11072614 | Apr 16, 2038 | in 12 yr | SubstanceU-4251 |
| 11752154 | Sep 04, 2038 | in 12 yr 5 mo | ProductU-4251 |
| 12213982 | Sep 04, 2038 | in 12 yr 5 mo | U-4251 |
| 12257252 | Mar 06, 2042 | in 15 yr 11 mo | U-4250 |
