Viewing data from:

SEPHIENCE

NDA

SEPIAPTERIN | N219666 | PTC THERAPEUTICS INC

2 strengths4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Apr. 16, 2038

Sep. 4, 2038

Sep. 4, 2038

Mar. 6, 2042

NCE

Jul. 28, 2030

ODE-542

Jul. 28, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria NCT05166161	Phase 3	Active	PTC Therapeutics	200	2022-02-14 → 2026-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 29, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG/PACKET

RLD

4 patents2 exclusivities▴

POWDER;ORAL | Approved: Jul 28, 2025

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11072614	Apr 16, 2038	—	Yes	—	—
11752154	Sep 4, 2038	—	—	Yes	—
12213982	Sep 4, 2038	—	—	—	—
12257252	Mar 6, 2042	—	—	—	—

Exclusivities (2)

Code	Date	Status
NCE	Jul 28, 2030	Active
ODE-542	Jul 28, 2032	Active

#002 — 1GM/PACKET

RLD

4 patents2 exclusivities▾

POWDER;ORAL | Approved: Jul 28, 2025

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

PTC Therapeutics received orphan drug exclusivity for Sephience (sepiapterin) for NDA 219666, Supplement 002.

New: New record

ADDED7/1/2026

New: New record