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Last Updated: December 22, 2024

EDARAVONE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Edaravone

A generic version of EDARAVONE was approved as edaravone by DR REDDYS on May 6th, 2024.

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Recent Clinical Trials for EDARAVONE

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SponsorPhase
Simcere Pharmaceutical Co., LtdPhase 3
Xiangya Hospital of Central South UniversityPhase 3
First Affiliated Hospital of Guangxi Medical UniversityN/A

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Paragraph IV (Patent) Challenges for EDARAVONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RADICAVA ORS Oral Suspension edaravone 105 mg/5 mL 215446 1 2023-04-20

US Patents and Regulatory Information for EDARAVONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys EDARAVONE edaravone SOLUTION;INTRAVENOUS 215917-001 May 6, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xgen Pharms EDARAVONE edaravone SOLUTION;INTRAVENOUS 217565-002 Oct 31, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma EDARAVONE edaravone SOLUTION;INTRAVENOUS 215508-001 May 6, 2024 AP 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

EDARAVONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Edaravone

Introduction to Edaravone

Edaravone, an antioxidant and free-radical scavenger, is primarily used to treat amyotrophic lateral sclerosis (ALS), a progressive and fatal neuromuscular disease. Approved by the FDA in 2017, edaravone has been gaining traction in the pharmaceutical market due to its efficacy in slowing down the progression of ALS, although it does not reverse nerve damage or muscle weakness[5].

Market Growth and Projections

The edaravone market is anticipated to experience significant growth over the coming years. Here are some key projections:

  • Global Market Size: The edaravone market was valued at USD 1243.7 million in 2023 and is expected to reach USD 2342.5 million by 2031, growing at a compound annual growth rate (CAGR) of 8.3% from 2024 to 2031[4].
  • Geographical Expansion: The market is segmented geographically, with North America currently holding the largest market share due to high prevalence of ALS and technological advancements. Europe, particularly Russia, also holds a significant share due to increased genetic disorders and refined medical facilities. The Asia-Pacific region is expected to account for the largest market share in the coming years due to the rising incidence of neurodegenerative diseases and the demand for cost-efficient therapeutics[1].

Key Drivers of Market Growth

Several factors are driving the growth of the edaravone market:

  • Increasing Incidence of ALS: The growing prevalence of ALS and other neurodegenerative diseases is a major driver. ALS affects approximately 5 out of every 100,000 individuals in the United States, with a high mortality rate within 30 months of symptom onset[5].
  • Regulatory Approvals: The FDA approval of edaravone in 2017 has significantly boosted its market acceptance and demand[5].
  • Research and Development: Significant investments in R&D are improving drug efficacy and expanding its applications. Technological advancements and ongoing clinical trials are expected to further enhance market growth[1][4].
  • Cost-Efficiency: Increasing demand for cost-efficient products, especially in developing regions, is another factor contributing to market expansion[1].

Financial Performance and Forecasts

The financial trajectory of edaravone is marked by several key indicators:

  • Revenue Growth: Companies like Mitsubishi Tanabe Pharma, which produces edaravone under the brand name Radicava, have seen revenue growth. For example, in the first quarter of FY2021, the company reported a revenue increase of 3.6% year-on-year, with overseas sales rising by 14.7%[2].
  • Operating Profit: Despite challenges such as increased clinical trial costs and other non-recurring items, companies are forecasting positive operating profits. Mitsubishi Tanabe Pharma forecasted a core operating profit increase of 23.6% for FY2021[2].
  • Market Size Projections: The market size is expected to more than double by 2031, indicating a robust financial outlook driven by increasing demand and expanding applications[4].

Distribution Channels and End Users

The edaravone market is analyzed based on distribution channels and end users:

  • Distribution Channels: The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant distribution channel due to the nature of the treatment, which often requires medical supervision[1].
  • End Users: The primary end users include hospitals, clinics, specialty clinics, and home healthcare services. The demand from these sectors is driven by the need for effective treatments for ALS and other neurodegenerative diseases[1].

Challenges and Implications

While the market is growing, there are several challenges and implications to consider:

  • Side Effects: Edaravone is associated with several side effects, which can hamper market growth. Managing these side effects and improving patient safety are critical for sustained market expansion[1].
  • Clinical Trial Costs: Increased costs associated with clinical trials, particularly for global projects, can impact the financial performance of companies involved in edaravone production[2].
  • Access to Therapy: Limited patient access and restrictive payer environments can also affect the broader adoption of edaravone, despite its clinical efficacy[5].

Regional Analysis

The edaravone market is analyzed at a country level, highlighting regional differences:

  • North America: This region holds the largest market share due to high prevalence of ALS and significant investments in R&D[1].
  • Europe: Russia accounts for the second-largest market share in Europe, driven by increased genetic disorders and advanced medical facilities[1].
  • Asia-Pacific: This region is expected to grow significantly due to the rising incidence of neurodegenerative diseases and the demand for cost-efficient treatments[1].

Key Takeaways

  • The edaravone market is projected to grow significantly, driven by increasing incidence of ALS and other neurodegenerative diseases.
  • Regulatory approvals and investments in R&D are key drivers of market growth.
  • The market is segmented geographically, with North America and Asia-Pacific being significant regions.
  • Challenges such as side effects and clinical trial costs need to be managed to sustain market growth.

FAQs

  1. What is edaravone used for?

    • Edaravone is used to treat amyotrophic lateral sclerosis (ALS), a progressive and fatal neuromuscular disease. It helps slow down the worsening of ALS but does not reverse nerve damage or muscle weakness[5].
  2. What is the current market size of edaravone?

    • The edaravone market was valued at USD 1243.7 million in 2023[4].
  3. What is the projected growth rate of the edaravone market?

    • The market is expected to grow at a CAGR of 8.3% from 2024 to 2031[4].
  4. Which region holds the largest market share for edaravone?

    • North America currently holds the largest market share due to high prevalence of ALS and technological advancements[1].
  5. What are the main challenges facing the edaravone market?

    • The main challenges include side effects associated with edaravone, increased clinical trial costs, and limited patient access due to restrictive payer environments[1][2][5].

Cited Sources

  1. Data Bridge Market Research - Global Edaravone Market – Industry Trends and Forecast to 2028[1].
  2. Mitsubishi Tanabe Pharma - Financial Information for the 1st Quarter of Fiscal Year Ending March 2021[2].
  3. Central News Channel Nebraska - Edaravone Injection Market Trends, Size, and Industry Share to 2032[3].
  4. Market Research Intellect - Edaravone Market Size and Projections[4].
  5. The American Journal of Managed Care - Edaravone in the Treatment of Amyotrophic Lateral Sclerosis[5].

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