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AMRIX

NDA

CYCLOBENZAPRINE HYDROCHLORIDE | N021777 | TEVA PHARMACEUTICALS INTERNATIONAL GMBH

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Adare Pharmaceuticals, Inc. et al v. Inventia Healthcare Limited 1:2018cv01079	D. Del.	2018-07-20	Terminated 2019-03-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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 Teva Pharmaceuticals FDA-2016-P-1873 · 7 docket documents Teva Pharmaceuticals filed this petition under 21 USC 355(q) requesting that the FDA require any ANDA for cyclobenzaprine hydrochloride extended-release capsules referencing AMRIX to conduct a bioequivalence study demonstrating that the proposed generic product is bioequivalent to AMRIX when adminis	505(q)	2016-07-01	Partially Denied	Teva Pharmaceuticals
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 | 6 NDCs (2 brand, 4 generic)

Highest NADAC/Unit

$66.57

per ea

Lowest NADAC/Unit

$0.8887

per ea

Brand NDCs

Generic NDCs

Avg Brand: $66.40

Avg Generic: $1.09

98% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
63459070160AMRIX ER 30 MG CAPSULE	$66.57	EA	Brand	$0.8887	2026-01-01
63459070060AMRIX ER 15 MG CAPSULE	$66.23	EA	Brand	$1.29	2026-01-01
00115143613CYCLOBENZAPRINE ER 15 MG CAP	$1.29	EA	Generic	—	2026-06-17
00093192006CYCLOBENZAPRINE ER 15 MG CAP	$1.29	EA	Generic	—	2026-06-17
00115143713CYCLOBENZAPRINE ER 30 MG CAP	$0.8887	EA	Generic	—	2026-06-17
00093192106CYCLOBENZAPRINE ER 30 MG CAP	$0.8887	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$28.24

Highest Price

$2792.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00115-1437-13CYCLOBENZAPRINE HCL 30MG CAP,SA	$401.30	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
00115-1437-13CYCLOBENZAPRINE HCL 30MG CAP,SA	$31.77	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
63459-0701-60AMRIX 30MG ER CAPSULES	$2792.07	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
63459-0701-60AMRIX 30MG ER CAPSULES	$2451.08	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
63459-0700-60AMRIX	$2792.07	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
63459-0700-60AMRIX	$2216.54	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Amrix (2024)

Total Spending

$448K

Total Claims

148

Beneficiaries

Avg Cost/Unit

$55.64

Spending Trend

$3.0M(2019)→$1.2M(2020)→$845K(2021)→$594K(2022)→$577K(2023)→$448K(2024)

YoY Change:+2.7%

5yr CAGR:+7.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

8 letters from Drugs@FDA

Date	Submission	Document
Apr 26, 2024	SUPPL -19	View Letter (PDF)
Apr 26, 2019	SUPPL -17	View Letter (PDF)
May 27, 2016	SUPPL -14	View Letter (PDF)
Jun 11, 2013	SUPPL -6	View Letter (PDF)
Jun 11, 2013	SUPPL -9	View Letter (PDF)
Apr 16, 2013	SUPPL -12	View Letter (PDF)
Mar 26, 2008	SUPPL -3	View Letter (PDF)
Feb 12, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 1, 2007

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 1, 2007