EDARAVONE - Generic Drug Details

What are the generic drug sources for edaravone and what is the scope of patent protection?

Edaravone is the generic ingredient in three branded drugs marketed by Dr Reddys, Gland Pharma Ltd, Hikma, Long Grove Pharms, Xgen Pharms, and Mitsubishi Tanabe, and is included in seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Edaravone has twenty-one patent family members in fourteen countries.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EDARAVONE

International Patents:	21
US Patents:	5
Tradenames:	3
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	57
Patent Applications:	5,767
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARAVONE
What excipients (inactive ingredients) are in EDARAVONE?	EDARAVONE excipients list
DailyMed Link:	EDARAVONE at DailyMed

Recent Clinical Trials for EDARAVONE

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

Sponsor	Phase
Simcere Pharmaceutical Co., Ltd	Phase 3
Xiangya Hospital of Central South University	Phase 3
First Affiliated Hospital of Guangxi Medical University	N/A

See all EDARAVONE clinical trials

Generic filers with tentative approvals for EDARAVONE

Applicant	Application No.	Strength	Dosage Form
		30MG/100ML(0.3MG/ML)	INJECTABLE;INJECTION

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

Anatomical Therapeutic Chemical (ATC) Classes for EDARAVONE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Hikma	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	215508-001	May 6, 2024	AP	RX	No	No
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y

Expired US Patents for EDARAVONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018

International Patents for EDARAVONE

Country	Patent Number	Title	Estimated Expiration
Japan	2023087011	経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
Israel	282773	השעיה של edaravone למינהל אוראלי (Edaravone suspension for oral administration)
Brazil	112021008197	suspensão de edaravone para administração oral
Mexico	2024000663	SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)

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].