Viewing data from:

TONMYA

NDA

CYCLOBENZAPRINE HYDROCHLORIDE | N219428 | TONIX PHARMACEUTICALS INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Mar. 14, 2034

Mar. 14, 2034

Mar. 14, 2034

Mar. 14, 2034

Aug. 15, 2028

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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-7610 · 5 docket documents The law firm 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 FDA declare Cyclobenzaprine HCl Sublingual Tablets, 5.6 mg, suitable for submission as an Abbreviated New Drug Application, with the refe	Suitability	2026-07-08	Open	Hyman, Phelps & McNamara, P.C.
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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$29.58

per ea

Lowest NADAC/Unit

$29.58

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70792010230TONMYA 2.8 MG TABLET SL	$29.58	EA	Brand	—	2026-06-17
70792010260TONMYA 2.8 MG TABLET SL	$29.58	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 18, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.8MG

RLD

4 patents1 exclusivity▴

TABLET;SUBLINGUAL | Approved: Aug 15, 2025

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9636408	Mar 14, 2034	—	—	Yes	—	—
9956188	Mar 14, 2034	—	—	Yes	—	—
10117936	Mar 14, 2034	—	—	Yes	—	—
10864175	Mar 14, 2034	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NP	Aug 15, 2028	Active