SEPHIENCE

Launch

sepiapterin

PTC Therapeutics

NDAORALPOWDER

Approved

Jul 2025

Lifecycle

Launch

Competitive Pressure

0/100

Clinical Trials

1

Clinical Trials (1)

NCT06302348Phase 3Recruiting

A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

Started Mar 2024

56 enrolled

Phenylketonuria

Loss of Exclusivity

LOE Date

Mar 6, 2042

194 months away

Patent Expiry

Mar 6, 2042

Exclusivity Expiry

Jul 28, 2030

Patent Records (4)

Patent #	Expiry	Type	Use Code
11072614	Apr 16, 2038	Substance	U-4251
11752154	Sep 4, 2038	Product	U-4251
12213982	Sep 4, 2038		U-4251
12257252	Mar 6, 2042		U-4250

Company

PTC Therapeutics

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers