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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

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2032

2033

2034

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2038

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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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of PTC923 (CNSA-001) in Primary Tetrahydrobiopterin (BH4) Deficient Participants With Hyperphenylalaninemia NCT03519711	Phase 1/2	Completed	PTC Therapeutics	8	2019-01-03 → 2020-10-02
A Study of CNSA-001 in Women With Diabetic Gastroparesis NCT03712124	Phase 2	Completed	PTC Therapeutics	21	2019-02-27 → 2019-10-08

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) · 4 use codes

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