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 three branded drugs marketed by Teva Pharms Intl, Apotex, Macleods Pharms Ltd, Novast Labs, Twi Pharms Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Anda Repository, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon, Sandoz, Sun Pharm Inds Ltd, Unichem, Watson Labs, and Janssen Res And Dev, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CYCLOBENZAPRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	24
NDAs:	25
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	58
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	40
Patent Applications:	1,997
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
Madigan Army Medical Center	Phase 4
Apsen Farmaceutica S.A.	Phase 3
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4

See all CYCLOBENZAPRINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		30MG	CAPSULE, EXTENDED RELEASE; ORAL
		15MG	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
Aiping Pharm Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	072854-001	Nov 19, 1991		DISCN	No	No
Aiping Pharm Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	072854-002	Feb 3, 2006		DISCN	No	No
Apotex	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206703-002	Jul 24, 2018		DISCN	No	No
Chartwell Rx	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	078218-003	Nov 3, 2020	AB	RX	No	No

Expired US Patents for CYCLOBENZAPRINE HYDROCHLORIDE

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

CYCLOBENZAPRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cyclobenzaprine Hydrochloride

Introduction

Cyclobenzaprine hydrochloride, a skeletal muscle relaxant, has been a significant player in the pharmaceutical market for decades. This article delves into the market dynamics, financial trajectory, and various factors influencing the cyclobenzaprine hydrochloride market.

Market Growth and CAGR

The global cyclobenzaprine market is anticipated to grow at a significant Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period. This growth is driven by the high prevalence of chronic pain conditions such as low back pain, osteoarthritis, and fibromyalgia among patients. According to the US Department of Health & Human Services, approximately 20.4% of adults suffer from chronic pain, with 7.4% experiencing high-impact chronic pain that frequently limits life or work activities[1].

Impact of COVID-19

The COVID-19 pandemic has significantly impacted the cyclobenzaprine market. With more people working from home, there was a notable increase in back and neck discomfort due to poor sitting positions, lack of ergonomic setups, and prolonged screen time. This led to an increased demand for cyclobenzaprine, which was also used in the treatment of COVID-19 patients. The pandemic accelerated the market growth, particularly in the segment focused on relieving muscle spasms[1].

Segmental Outlook

Relieve Muscle Spasms Segment

The relieve muscle spasms segment holds a prominent share in the global cyclobenzaprine market. Cyclobenzaprine is widely used to treat muscle spasms caused by acute, painful musculoskeletal problems. It works by reducing the release of molecules that induce muscular discomfort and swelling, making it a preferred treatment for tension, stress, overuse, and small injuries[1].

Fibromyalgia Treatment Segment

In addition to muscle spasms, cyclobenzaprine is also used in the treatment of fibromyalgia. This application segment is expected to grow as the awareness and diagnosis of fibromyalgia increase, contributing to the overall market expansion[4].

Regional Analysis

The global cyclobenzaprine market is segmented geographically into North America, Europe, Asia-Pacific, and the Rest of the World.

Asia-Pacific Region

The Asia-Pacific region is anticipated to hold a significant share and grow the fastest during the forecast period. Factors such as the expansion of the geriatric population, rising disposable income, and increasing healthcare expenditure in countries like India and China drive this growth. The rising prevalence of chronic pain conditions among adults and the elderly in this region further contributes to the market's expansion[1].

North America and Europe

North America and Europe also hold substantial market shares, driven by the high prevalence of chronic pain and the established healthcare infrastructure in these regions. The presence of major pharmaceutical companies and a well-developed distribution network support the market growth in these areas[1].

Market Players and Strategies

Key players in the cyclobenzaprine market, such as Teva and Trupharma, are focusing on strengthening their product portfolios and expanding their business globally. These companies are adopting strategies like product diversification, partnerships, and investments in research and development to maintain their market position[4].

Financial Trajectory

Cost and Pricing

Cyclobenzaprine hydrochloride is available in both generic and brand-name forms. The generic version is significantly cheaper, with a 30-tablet supply costing around $20 without insurance. Brand-name versions, such as Fexmid, are more expensive, with a 30-tablet supply costing approximately $135[2].

Insurance Coverage

Cyclobenzaprine is generally covered by health insurance and Medicaid, although some plans may impose restrictions like prior authorization or quantity limits. Medicare Part D drug plans also cover immediate-release cyclobenzaprine, but extended-release versions may face age restrictions[2].

Savings and Alternatives

Savings cards, such as those offered by SingleCare, can significantly reduce the cost of cyclobenzaprine, making it more affordable for patients without insurance. Alternative medications like NSAIDs, antidepressants, and other muscle relaxants may also offer cost-effective solutions, although their efficacy and safety profiles differ from cyclobenzaprine[2].

Discontinuation of Brand-Name Flexeril

The brand-name version of cyclobenzaprine, Flexeril, was discontinued by Merck. The primary reason is believed to be financial, as generic versions of cyclobenzaprine became widely available and cheaper, making it difficult for Flexeril to remain profitable. Legal battles over patent validity also played a role in the decline of Flexeril[5].

Market Trends and Drivers

• Increasing Prevalence of Chronic Pain: The rising prevalence of chronic pain conditions is a major driver of the cyclobenzaprine market.
• Aging Population: The expansion of the geriatric population, particularly in the Asia-Pacific region, contributes to market growth.
• Advancements in Healthcare: Continuous improvements in healthcare infrastructure and expenditure in various regions support market expansion.
• COVID-19 Impact: The pandemic has accelerated the demand for cyclobenzaprine due to increased instances of back and neck discomfort[1][4].

Challenges and Restraints

• Side Effects: Common side effects like drowsiness, dizziness, dry mouth, and constipation can limit the long-term use of cyclobenzaprine.
• Regulatory Restrictions: Age restrictions and prior authorization requirements can affect the market growth, especially for extended-release versions.
• Generic Competition: The availability of generic versions at lower prices can reduce the market share of brand-name drugs[2][4].

Key Takeaways

• The global cyclobenzaprine market is growing at a CAGR of 4.2%, driven by chronic pain prevalence and COVID-19 impacts.
• The relieve muscle spasms segment holds a significant market share.
• The Asia-Pacific region is expected to grow the fastest due to demographic and economic factors.
• Generic versions of cyclobenzaprine are more affordable and widely available.
• Insurance coverage and savings cards can reduce out-of-pocket costs for patients.

FAQs

1. What is the primary use of cyclobenzaprine hydrochloride? Cyclobenzaprine hydrochloride is primarily used to relieve muscle spasms and treat conditions such as back pain, neck pain, and fibromyalgia.

2. How has the COVID-19 pandemic affected the cyclobenzaprine market? The COVID-19 pandemic has increased the demand for cyclobenzaprine due to the rise in back and neck discomfort among people working from home.

3. Which region is expected to grow the fastest in the cyclobenzaprine market? The Asia-Pacific region is anticipated to grow the fastest due to factors such as an expanding geriatric population and rising healthcare expenditure.

4. Is cyclobenzaprine covered by insurance? Yes, cyclobenzaprine is generally covered by health insurance and Medicaid, although some plans may have restrictions.

5. Why was the brand-name Flexeril discontinued? Flexeril was discontinued primarily due to financial reasons, as generic versions of cyclobenzaprine became widely available and cheaper.

Cited Sources:

1. OMR Global: Cyclobenzaprine Market Share, Trends, Growth | Analysis and Forecast.
2. SingleCare: How much is cyclobenzaprine HCl (Fexmid) without insurance?
3. Minnesota Department of Human Services: Amrix / Minnesota Department of Human Services.
4. Cognitive Market Research: Cyclobenzaprine Drug Market Report 2024 (Global Edition).
5. Live Free Recovery Services: Why Was Flexeril Discontinued?