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JOURNAVX

NDA

SUZETRIGINE | N219209 | VERTEX PHARMACEUTICALS INC

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

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Today

11834441

Dec. 4, 2040

NCE

Jan. 30, 2030

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

3 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants NCT07570069	Phase 1	Active	Vertex Pharmaceuticals Incorporated	18	2026-05-07 → 2026-07-11
Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU)NCT07672015	Phase 4	Not Yet Recruiting	University of California, San Diego	100	2026-06 → 2027-06
The Role of NaV1.8 in Human Pain Models NCT07511400	Early Phase 1	Completed	Medical University of Vienna	67	2026-04-21 → 2026-06-09

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LEE PHARMA LTDSUZETRIGINE ASD

DMF 423802025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 26, 2026	SUPPL -9	View Letter (PDF)
Feb 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: Jan 30, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11834441	Dec 4, 2040	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NCE	Jan 30, 2030	Active