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Last Updated: December 22, 2024

FLEXERIL Drug Patent Profile


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

Flexeril is a drug marketed by Janssen Res And Dev and is included in one NDA.

The generic ingredient in FLEXERIL 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.

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Summary for FLEXERIL
Drug patent expirations by year for FLEXERIL
Recent Clinical Trials for FLEXERIL

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

SponsorPhase
Augusta UniversityPhase 4
Neurana Pharmaceuticals, Inc.Phase 1
Cognitive Research CorporationPhase 1

See all FLEXERIL clinical trials

US Patents and Regulatory Information for FLEXERIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 DISCN Yes 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

Expired US Patents for FLEXERIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

FLEXERIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cyclobenzaprine (Flexeril)

Market Overview

Cyclobenzaprine, commonly known by the brand name Flexeril, is a muscle relaxant used to treat muscle spasms and discomfort. The market for this drug is influenced by several key factors, including demographic shifts, pain management strategies, and advancements in healthcare delivery.

Prevalence of Chronic Pain

The global cyclobenzaprine market is driven by the high 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].

Non-Opioid Alternatives

The growing awareness of the need for non-opioid alternatives to manage pain, especially in the wake of the opioid epidemic, has significantly boosted the demand for cyclobenzaprine. As a non-narcotic option, it offers a safer alternative for addressing muscle discomfort and tension[3].

Demographic Factors

The aging population is another significant driver of the cyclobenzaprine market. Elderly individuals often experience musculoskeletal pain and spasms, making this demographic a key target for the drug. Additionally, an increasingly sedentary lifestyle and rise in stress-related muscular conditions have contributed to its popularity[3].

Healthcare Delivery Advancements

Telemedicine and digital health platforms have become integral in healthcare delivery, enabling easier access to prescriptions for cyclobenzaprine and enhancing patient education. This has further expanded the market reach of the drug[3].

Market Segmentation

By Application

The relieve muscle spasms segment holds a significant market share and is anticipated to grow prominently during the forecast period. Cyclobenzaprine is used to treat muscle spasms caused by acute, painful musculoskeletal problems by relaxing muscles and reducing discomfort[1].

By Region

The global cyclobenzaprine market is segmented geographically into North America, Europe, Asia-Pacific, and the Rest of the World. The Asia-Pacific region is expected to hold a major share and grow the fastest during the forecast period, driven by the expansion of the geriatric population, rising disposable income, and increasing healthcare expenditure in countries like India and China[1].

Financial Trajectory

Market Growth

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 increasing demand for effective pain management solutions and the expanding geriatric population[1].

Revenue Projections

The market size is estimated to increase substantially from 2024 to 2031, with the Asia-Pacific region contributing significantly to this growth. The revenue from the relieve muscle spasms segment is expected to be a major contributor to the overall market revenue[1][4].

Key Players and Strategies

Pharmaceutical companies involved in the cyclobenzaprine market are focusing on novel formulations and combination therapies to stay competitive. The market is also influenced by regulatory procedures and approvals, which companies must navigate to ensure compliance and maintain market share[3].

Regional Analysis

Asia-Pacific

This region is expected to hold a significant share in the global cyclobenzaprine market due to factors such as the rising prevalence of chronic pain conditions among adults and the elderly, and increased healthcare expenditure in countries like India and China[1].

North America

North America, particularly the US and Canada, is also a significant market for cyclobenzaprine. The region benefits from advanced healthcare infrastructure and a high awareness of pain management options, contributing to the drug's market share[1].

Europe

Europe, including countries like the UK, Germany, Italy, Spain, and France, also represents a substantial market. The region's aging population and high healthcare standards drive the demand for cyclobenzaprine[1].

Competitive Landscape

The cyclobenzaprine market is competitive, with several pharmaceutical companies vying for market share. Companies are investing in research and development to improve formulations and expand their product portfolios. The competitive landscape is also influenced by regulatory environments and the need for continuous innovation to meet changing healthcare needs[3].

Challenges and Opportunities

Regulatory Challenges

Pharmaceutical companies must navigate complex regulatory landscapes to ensure compliance. This includes obtaining necessary approvals and adhering to quality assurance criteria and technical tests[3].

Opportunities in Non-Opioid Pain Management

The growing need for non-opioid pain management solutions presents a significant opportunity for cyclobenzaprine. As healthcare providers and patients seek safer alternatives to opioids, the demand for this drug is likely to increase[3].

Technological Advancements

Advancements in telemedicine and digital health platforms offer opportunities for easier access to prescriptions and enhanced patient education, further expanding the market reach of cyclobenzaprine[3].

Financial Analysis

Capital Expenditure and Operating Expenses

Setting up a cyclobenzaprine manufacturing plant involves significant capital expenditure (CapEx) and operating expenses (OpEx). Companies must conduct detailed financial analyses, including income and expenditure projections, taxation, depreciation, and liquidity analysis, to ensure the viability of their projects[3].

Return on Investment (ROI) and Net Present Value (NPV)

The financial viability of a cyclobenzaprine manufacturing plant is evaluated through metrics such as ROI and NPV. These analyses help companies determine the expected profitability and long-term value of their investments[3].

Key Takeaways

  • The global cyclobenzaprine market is driven by the high prevalence of chronic pain conditions and the need for non-opioid pain management solutions.
  • The Asia-Pacific region is expected to hold a significant share and grow the fastest during the forecast period.
  • The relieve muscle spasms segment is a major contributor to the market revenue.
  • Pharmaceutical companies must navigate complex regulatory environments and invest in research and development to stay competitive.
  • Technological advancements in healthcare delivery are expanding the market reach of cyclobenzaprine.

FAQs

What is the primary driver of the global cyclobenzaprine market?

The primary driver of the global cyclobenzaprine market is the high prevalence of chronic pain conditions such as low back pain, osteoarthritis, and fibromyalgia.

Which region is expected to hold the largest share in the global cyclobenzaprine market?

The Asia-Pacific region is expected to hold the largest share in the global cyclobenzaprine market, driven by the expansion of the geriatric population and increasing healthcare expenditure.

What is the significance of cyclobenzaprine in pain management?

Cyclobenzaprine is significant in pain management as it offers a non-narcotic alternative for addressing muscle discomfort and tension, particularly in the context of the opioid epidemic.

How does telemedicine impact the cyclobenzaprine market?

Telemedicine and digital health platforms have enabled easier access to prescriptions for cyclobenzaprine and enhanced patient education, further expanding the market reach of the drug.

What are the key financial considerations for setting up a cyclobenzaprine manufacturing plant?

Key financial considerations include capital expenditure, operating expenses, income and expenditure projections, taxation, depreciation, and liquidity analysis to ensure the viability of the project.

Sources

  1. OMR Global: Cyclobenzaprine Market Share, Trends, Growth | Analysis and Forecast.
  2. Flex Ltd.: Q4 Fiscal Year 2024 Transcript.
  3. IMARC Group: Cyclobenzaprine (Flexeril) Manufacturing Plant Project Report 2024.
  4. Cognitive Market Research: Cyclobenzaprine Drug Market Report 2024 (Global Edition).
  5. Stock Titan: Argus Research Initiates Equity Research Report Coverage on FlexShopper.

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