FDA Orange Book · active-ingredient family
Sepiapterin
Sepiapterin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SEPHIENCE · NDA 219666
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
4
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SEPHIENCERLD×2 | PTC THERAP | NDA 219666 | — | Jul 28, 2025 |
Marketing exclusivity (4)
- 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
- 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 |
| 12213982 | Sep 04, 2038 | in 12 yr 5 mo | U-4251 |
| 11752154 | Sep 04, 2038 | in 12 yr 5 mo | ProductU-4251 |
| 12257252 | Mar 06, 2042 | in 15 yr 11 mo | U-4250 |
Sepiapterin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
