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FLEXERIL

NDA

CYCLOBENZAPRINE HYDROCHLORIDE | N017821 | JANSSEN RESEARCH AND DEVELOPMENT LLC

2 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Newcastle Bioscience, LLC FDA-2025-P-0982 Newcastle Bioscience LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyclobenzaprine Orally Disintegrating Tablets in 7.5 mg strength suitable for submission as an abbreviated new drug application, with the refere	Suitability	2025-03-28	Open	Newcastle Bioscience
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-4935 Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Cyclobenzaprine HCl Orally Disintegrating Tablets in 2.5 mg, 3.75 mg, and 7.5 mg strengths suitable for submission of an ANDA, with the	Suitability	2024-10-23	Open	Hyman
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4284 Newcastle Bioscience LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyclobenzaprine Orally Disintegrating Tablets in 5 mg and 10 mg strengths suitable for submission as an ANDA, with the reference listed drug	Suitability	2023-10-03	Open	Newcastle Bioscience LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy NCT07664956	Phase 4	Not Yet Recruiting	Christiana Care Health Services	36	2026-07-01 → 2026-12-01

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

API Supply Chain6 active DMFs5 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

HETERO DRUGS LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 213922008

DERIVADOS QUIMICOS SAUCYCLOBENZAPRINE HYDROCHLORIDE

DMF 235212010

JUBILANT PHARMOVA LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 247192011

MACLEODS PHARMACEUTICALS LTDCYCLOBENZAPRINE HYDROCHLORIDE EXTENDED RELEASE PELLETS

DMF 299552015

RL FINE CHEM PVT LTDCYCLOBENZAPRINE HYDROCHLORIDE

DMF 331472018

UNICHEM LABORATORIES LTDCYCLOBENZAPRINE HYDROCHLORIDE USP

DMF 346542020

GANES CHEMICALS INC PENNSVILLE DIVInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 58101985

SUMIKA FINE CHEMICALS CO LTDInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 80651989

SIFAVITOR SRLInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 95101992

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveCYCLOBENZAPRINE HYDROCHLORIDE

DMF 183172005

FLEMING LABORATORIES LTDInactiveCYCLOBENZAPRINE HYDROCHLORIDE USP BULK

DMF 230632009

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2013	SUPPL -51	View Letter (PDF)
Jun 4, 2004	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982