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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

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Newcastle Bioscience, LLC FDA-2025-P-0982 · 10 docket documents 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, LLC
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-4935 · 7 docket documents 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	Granted	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4284 · 7 docket documents 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	Granted	Newcastle Bioscience LLC
Citizen Petition from Foley & Lardner LLP FDA-2009-P-0168 · 4 docket documents Foley & Lardner LLP filed this ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting approval to submit an ANDA for Cyclobenzaprine Hydrochloride Extended-Release Tablets in 15mg and 30mg strengths, changing the dosage form from extended-release	Other	2009-04-03	Granted	Foley & Lardner LLP

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

Clinical Trials

35 trials from ClinicalTrials.gov, 25 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm NCT00246389	Phase 4	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	1,000	— → 2004-07
Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions NCT00778037	N/A	Completed	Ranbaxy Laboratories Limited	40	2006-09 → 2006-11
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment NCT02862977	Phase 3	Completed	EMS	414	2017-11-10 → 2019-12-20
Use of Cyclobenzaprine After Vaginal Surgery NCT01081990	N/A	Completed	Endeavor Health	63	2010-04 → 2014-08-01
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial NCT00790270	Phase 2	Completed	Stony Brook University	61	2003-01 → 2004-01
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.NCT01490788	Phase 1	Completed	Tonix Pharmaceuticals, Inc.	30	2011-11-18 → 2011-12-30
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions NCT02421679	Phase 2	Completed	Tonix Pharmaceuticals, Inc.	159	2015-04-14 → 2016-05-26
A Randomized Study of Three Medication Regimens for Acute Low Back Pain NCT01587274	Phase 4	Completed	Montefiore Medical Center	323	2012-04 → 2014-12
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients NCT02589275	Phase 3	Completed	Tonix Pharmaceuticals, Inc.	375	2015-08-04 → 2016-09-28
Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults NCT01634412	Phase 1	Completed	Tonix Pharmaceuticals, Inc.	24	2012-06 → 2014-01

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 BIOSYS 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