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Last Updated: December 22, 2024

CYCLOBENZAPRINE Drug Patent Profile


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Which patents cover Cyclobenzaprine, and when can generic versions of Cyclobenzaprine launch?

Cyclobenzaprine is a drug marketed by 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, and Watson Labs. and is included in twenty-three NDAs.

The generic ingredient in CYCLOBENZAPRINE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclobenzaprine

A generic version of CYCLOBENZAPRINE was approved as cyclobenzaprine hydrochloride by ACTAVIS LABS FL INC on May 3rd, 1989.

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US Patents and Regulatory Information for CYCLOBENZAPRINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rubicon CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 208170-003 May 31, 2017 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Oxford Pharms CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077209-001 Oct 4, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073143-001 Nov 27, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722-003 May 12, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CYCLOBENZAPRINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cyclobenzaprine Hydrochloride

Introduction

Cyclobenzaprine hydrochloride, a centrally acting skeletal muscle relaxant, has been a vital component in the pharmaceutical industry for treating various musculoskeletal conditions. This article explores the market dynamics, financial trajectory, and key factors influencing the cyclobenzaprine hydrochloride market.

Market Growth and CAGR

The global cyclobenzaprine market is projected to grow at a significant Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period. This growth is largely driven by the increasing prevalence of chronic pain conditions such as low back pain, osteoarthritis, and fibromyalgia. 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][4].

Impact of COVID-19

The COVID-19 pandemic has had a notable impact on the cyclobenzaprine market. With more people working from home, there was an 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, particularly in the segment focused on relieving muscle spasms. The pandemic accelerated market growth, contributing to the overall expansion of the cyclobenzaprine market[1][4].

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][4].

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 awareness and diagnosis of fibromyalgia increase, contributing to the overall market expansion[1][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][4].

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][4].

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[1][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[1].

Insurance Coverage

The cost-effectiveness of cyclobenzaprine, especially in its generic form, makes it more accessible to a wider patient population. Insurance coverage also plays a crucial role in making this medication affordable for those who need it, further driving market growth.

Market Trends and Drivers

Increasing Prevalence of Chronic Pain

The rising prevalence of chronic pain conditions is a major driver of the cyclobenzaprine market. Chronic pain affects a significant portion of the adult population, and the demand for effective treatments like cyclobenzaprine continues to grow[1][4].

Aging Population

The expansion of the geriatric population, particularly in the Asia-Pacific region, contributes to market growth. Older adults are more prone to chronic pain conditions, increasing the demand for cyclobenzaprine[1][4].

Advancements in Healthcare

Continuous improvements in healthcare infrastructure and expenditure in various regions support market expansion. Better diagnostic tools and increased awareness of chronic pain conditions lead to more prescriptions for cyclobenzaprine[1][4].

COVID-19 Impact

The pandemic has accelerated the demand for cyclobenzaprine due to increased instances of back and neck discomfort. This has been a significant factor in the recent market growth, particularly in the segment focused on relieving muscle spasms[1][4].

Mechanism of Action and Clinical Uses

Cyclobenzaprine is a centrally acting skeletal muscle relaxant that works within the central nervous system to reduce muscle hyperactivity. It is primarily used as an adjunct to rest and physical therapy to relieve muscle spasms associated with acute, painful musculoskeletal conditions for short-term use (up to 2 or 3 weeks)[5].

FDA-Approved Indication

Cyclobenzaprine is FDA-approved for the treatment of muscle spasms associated with acute, painful musculoskeletal conditions. It is not recommended for long-term use due to the lack of evidence supporting its effectiveness beyond short durations[5].

Off-label Clinical Uses

While primarily used for muscle spasms, cyclobenzaprine is also used off-label for treating fibromyalgia and other chronic pain conditions. Its effectiveness in reducing local pain and tenderness, and increasing the range of motion, makes it a versatile treatment option[5].

Pharmacokinetics

Cyclobenzaprine has a time to peak plasma concentration of 7 to 8 hours for extended-release formulations and approximately 4 hours for immediate release formulations. It is highly bound to plasma protein (93%) and primarily binds to alpha-1 glycoprotein. Food can increase the extent and rate of absorption of cyclobenzaprine[5].

Potential for Addiction

Cyclobenzaprine is generally prescribed for short-term use and is not considered highly addictive, especially in short durations. However, long-term use can lead to dependency and tolerance, requiring higher doses to achieve the same effect. It is essential to use cyclobenzaprine as part of a broader treatment plan that includes rest and physical therapy to minimize the risk of dependency[2].

Market Size and Forecast

The global cyclobenzaprine market size is expected to increase at a CAGR of 3 to 5 percent from its estimated valuation by 2031. The market is segmented based on application (hospital, drug store) and product (tablet, capsule) across geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[3].

Key Takeaways

  • Market Growth: The global cyclobenzaprine market is expected to grow at a CAGR of 4.2% driven by the increasing prevalence of chronic pain conditions.
  • Regional Dominance: The Asia-Pacific region is anticipated to hold a significant share and grow the fastest during the forecast period.
  • Market Segments: The relieve muscle spasms segment holds a prominent share, with fibromyalgia treatment also contributing to market growth.
  • Financial Factors: The cost-effectiveness of generic cyclobenzaprine and insurance coverage make it more accessible.
  • COVID-19 Impact: The pandemic has accelerated market growth due to increased instances of back and neck discomfort.

FAQs

What is the primary use of cyclobenzaprine hydrochloride?

Cyclobenzaprine hydrochloride is primarily used as an adjunct to rest and physical therapy to relieve muscle spasms associated with acute, painful musculoskeletal conditions.

How does cyclobenzaprine hydrochloride work?

Cyclobenzaprine hydrochloride works within the central nervous system to reduce muscle hyperactivity by inhibiting nerve signals and reducing the release of molecules that induce muscular discomfort and swelling.

What are the key drivers of the cyclobenzaprine market?

The key drivers include the increasing prevalence of chronic pain conditions, the expansion of the geriatric population, advancements in healthcare, and the impact of the COVID-19 pandemic.

Is cyclobenzaprine hydrochloride addictive?

Cyclobenzaprine hydrochloride is not highly addictive when used for short-term periods but can lead to dependency and tolerance with long-term use.

Which regions are expected to dominate the cyclobenzaprine market?

The Asia-Pacific region is anticipated to hold a significant share and grow the fastest, followed by North America and Europe.

Sources

  1. DrugPatentWatch: CYCLOBENZAPRINE HYDROCHLORIDE - Generic Drug Details
  2. Empowered Recovery Center: Is Cyclobenzaprine Addictive?
  3. MarketResearchIntellect: Global cyclobenzaprine drug market size and forecast 2
  4. OMR Global: Cyclobenzaprine Market Share, Trends, Growth | Analysis and Forecast
  5. NCBI: StatPearls: Cyclobenzaprine

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