CYCLOBENZAPRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for cyclobenzaprine hydrochloride and what is the scope of freedom to operate?

Cyclobenzaprine hydrochloride is the generic ingredient in four branded drugs marketed by Teva Pharms Intl, Apotex, Macleods Pharms Ltd, Novast Labs, Twi Pharms Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon Research, Sandoz, Sun Pharm Inds Ltd, Tp Anda Holdings, Unichem, Watson Labs, Janssen Res And Dev, and Tonix, and is included in twenty-six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cyclobenzaprine hydrochloride has fifty-three patent family members in twenty-seven countries.

There are ten drug master file entries for cyclobenzaprine hydrochloride. Sixty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CYCLOBENZAPRINE HYDROCHLORIDE

International Patents:	53
US Patents:	4
Tradenames:	4
Applicants:	24
NDAs:	26
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	61
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	43
Patent Applications:	2,279
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYCLOBENZAPRINE HYDROCHLORIDE
What excipients (inactive ingredients) are in CYCLOBENZAPRINE HYDROCHLORIDE?	CYCLOBENZAPRINE HYDROCHLORIDE excipients list
DailyMed Link:	CYCLOBENZAPRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CYCLOBENZAPRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	PHASE2
Mclean Hospital	PHASE2
United States Department of Defense	PHASE2

See all CYCLOBENZAPRINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		15MG	CAPSULE, EXTENDED RELEASE; ORAL
		30MG	CAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CYCLOBENZAPRINE HYDROCHLORIDE

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Anatomical Therapeutic Chemical (ATC) Classes for CYCLOBENZAPRINE HYDROCHLORIDE

M03BX	Other centrally acting agents
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for CYCLOBENZAPRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMRIX	Extended-release Capsule	cyclobenzaprine hydrochloride	15 mg and 30 mg	021777	1	2008-08-11

US Patents and Regulatory Information for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	078218-001	Apr 18, 2008	AB	RX	No	No
Rising	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	073144-003	Mar 25, 2013		DISCN	No	No
Pliva	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	074421-001	Sep 29, 1995		DISCN	No	No

Expired US Patents for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982	3,454,643
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982	3,454,643
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007	9,375,410

International Patents for CYCLOBENZAPRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2021143208	シクロベンザプリン塩酸塩およびアミトリプチリン塩酸塩の共融製剤 (EUTECTIC FORMULATIONS OF CYCLOBENZAPRINE HYDROCHLORIDE AND AMITRIPTYLINE HYDROCHLORIDE)
Hungary	E066883
Portugal	2968992

Market Dynamics and Financial Trajectory for Cyclobenzaprine Hydrochloride

Last updated: September 18, 2025

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Introduction

Cyclobenzaprine Hydrochloride stands as a cornerstone in the management of acute musculoskeletal conditions. Broadly prescribed to alleviate muscle spasms and associated pain, it occupies a significant niche within the therapeutic landscape of skeletal muscle relaxants. This analysis explores the current market dynamics, growth drivers, competitive landscape, regulatory influences, and future financial trends shaping the trajectory of Cyclobenzaprine Hydrochloride.

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Market Overview and Scope

Cyclobenzaprine Hydrochloride, chemically similar to tricyclic antidepressants, has been FDA-approved since 1977, primarily marketed in formulations such as Flexeril, Amrix, and Fexmid. With an established presence in the healthcare system, its adherence to treatment regimens for acute musculoskeletal conditions sustains steady demand globally. The compound is commonly prescribed in outpatient settings, including hospitals, clinics, and private practice, underscoring its widespread clinical acceptance.

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Market Dynamics

1. Growing Incidence of Musculoskeletal Disorders

A primary growth driver for Cyclobenzaprine Hydrochloride remains the rising prevalence of musculoskeletal ailments due to aging populations, sedentary lifestyles, and increasing incidences of injuries and chronic conditions like fibromyalgia and arthritis. The Global Burden of Disease Study underscores musculoskeletal disorders as leading causes of disability globally, fueling demand for effective muscle relaxants [1].

2. Healthcare Spending and Prescription Trends

Rising healthcare expenditure amplifies accessibility to prescription medications. Governments and health insurers increasingly favor outpatient pharmacological management over invasive procedures, bolstering the use of muscle relaxants, including Cyclobenzaprine Hydrochloride.

3. Competitive Landscape

While Cyclobenzaprine faces competition from other muscle relaxants such as methocarbamol, carisoprodol, and tizanidine, its entrenched position is reinforced by its long history of use, generic availability, and established efficacy. Patent expirations have intensified generic competition, exerting downward pressure on prices but expanding access.

4. Regulatory Environment

Regulatory frameworks influence manufacturing, marketing, and prescribing behaviors. The FDA maintains stringent oversight of muscle relaxants, especially considering abuse potential associated with some agents. Cyclobenzaprine's classification as a potentially sedative drug necessitates monitoring, but it’s generally regarded as a safe option, reducing regulatory hurdles.

5. Pharmacological and Clinical Developments

Despite limited recent innovations, ongoing research into combination therapies and novel formulations aims to enhance pill compliance and reduce side effects. The development of extended-release formulations, such as Amrix, reflects market efforts to improve patient adherence and convenience.

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Economic and Financial Trajectory

1. Revenue Trends

Historically, Cyclobenzaprine's revenues have persisted steadily, driven mainly by generics. According to IQVIA data, the global market for muscle relaxants approximates $2 billion, with Cyclobenzaprine accounting for a substantial share due to high demand and widespread use [2].

2. Impact of Patent Expirations

Generic entry following patent expiration in the US around 2001 catalyzed price erosion but expanded market reach. This paradigm results in sustained high-volume, low-margin sales, characteristic of mature pharmaceutical markets.

3. Pricing Strategies and Market Segmentation

Manufacturers adopt competitive pricing to penetrate emerging markets, balancing profit margins against affordability. In countries with healthcare affordability issues, Cyclobenzaprine remains a cost-effective option, further supporting its sales trajectory.

4. Potential Future Growth

Projected compound annual growth rate (CAGR) for the muscle relaxants segment is estimated at 4-6% over the next five years, with Cyclobenzaprine likely maintaining a significant share due to absence of alternative therapies with superior safety profiles [3].

5. Impact of COVID-19

The pandemic initially suppressed elective care and outpatient prescriptions but later rebounded as remote healthcare infrastructure facilitated continued medication management. Supply chain disruptions, however, posed temporary challenges, but overall impact on Cyclobenzaprine’s market size remains minimal.

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Competitive and Strategic Considerations

1. Generic Dominance and Innovation

The predominance of generics constrains pricing power but ensures volume sales. Limited pipeline innovation hampers growth prospects; however, strategic formulation enhancements could provide differentiation.

2. Regional Market Variabilities

Developed markets like North America and Europe dominate demand due to higher healthcare spending, while emerging markets exhibit growing adoption driven by expanding healthcare infrastructure and increasing musculoskeletal disorder prevalence.

3. Pharmacovigilance and Safety Concerns

Cyclobenzaprine’s sedative side effects and potential for misuse necessitate rigorous pharmacovigilance. Regulatory agencies increasingly emphasize post-marketing surveillance, affecting marketing and prescribing.

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Future Outlook and Financial Trajectory

The future of Cyclobenzaprine Hydrochloride hinges on demographic trends, healthcare policies, and competitive pressures. Its financial trajectory is characterized by stable volume sales, modest growth, and a plateauing of innovation.

Key factors influencing future growth include:

• Aging Population: Continued demographic shifts will heighten demand.
• Healthcare Access: Improving healthcare infrastructure in emerging markets expands usage.
• Formulation Advancements: Developing extended-release or combination formulations may unlock incremental growth.
• Regulatory Landscape: Ongoing safety monitoring could impact prescribing patterns.

Overall, Cyclobenzaprine's financial trajectory projects stability with minimal growth, constrained mainly by the dynamics of generic market saturation and limited pipeline innovation.

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Key Takeaways

• Steady Demand: The consistent prevalence of musculoskeletal conditions sustains baseline demand.
• Generic Market Impact: Patent expirations have lowered prices but increased volume sales, ensuring revenue continuity.
• Limited Innovation: The lack of recent formulation or therapeutic improvements constrains growth potential.
• Emerging Market Opportunities: Growth in developing countries presents incremental expansion avenues.
• Regulatory Vigilance: Safety concerns necessitate ongoing pharmacovigilance, influencing marketing and prescribing.

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FAQs

1. What are the primary drivers behind the stable demand for Cyclobenzaprine Hydrochloride?
The high prevalence of musculoskeletal disorders globally, combined with the drug’s longstanding clinical acceptance and cost-effectiveness, ensures consistent demand.

2. How has patent expiration influenced the market for Cyclobenzaprine?
Patent expirations led to increased generic competition, reducing prices but enabling broader access and maintaining sales volume.

3. Are there innovative formulations or combination therapies in development for Cyclobenzaprine?
Limited recent innovation exists; however, extended-release formulations like Amrix exemplify efforts to improve compliance. No major new combination therapies are currently under FDA review.

4. How do regulatory and safety concerns impact the market outlook?
Regulatory emphasis on safety monitoring, especially regarding sedation and misuse, may influence prescribing patterns but have yet to substantially diminish demand.

5. What regional markets offer the most growth potential for Cyclobenzaprine Hydrochloride?
Emerging markets in Asia, Latin America, and parts of Africa are poised for growth owing to expanding healthcare infrastructure and increasing musculoskeletal disease burden.

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References

[1] GBD 2019 Musculoskeletal Disorders Collaborators. "Global, regional, and national burden of musculoskeletal disorders, 1990–2019." Lancet Rheumatol. 2020; 2(6): e383–e395.

[2] IQVIA. "Pharmaceutical Market Insights," 2022.

[3] MarketWatch. "Muscle Relaxants Market Size, Share & Trends Analysis," 2022.

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This comprehensive analysis outlines the key factors influencing the market and financial outlook for Cyclobenzaprine Hydrochloride, providing valuable insights for industry stakeholders, investors, and policymakers.