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, Hikma, Long Grove Pharms, Pharmobedient, Sandoz, Tanabe Pharma, and Kk Bcj-94, and is included in eight NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Edaravone has forty-three patent family members in twenty countries.

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

Summary for EDARAVONE

International Patents:	43
US Patents:	11
Tradenames:	3
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	66
Patent Applications:	6,320
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
Prilenia	PHASE3
Ferrer Internacional S.A.	PHASE3
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.	PHASE2

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
Gland	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	216199-002	May 6, 2024	AP	RX	No	No
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Dr Reddys	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	215917-001	May 6, 2024	AP	RX	No	No
Hikma	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	215508-001	May 6, 2024	AP	RX	No	No
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes

Expired US Patents for EDARAVONE

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

International Patents for EDARAVONE

Country	Patent Number	Title	Estimated Expiration
Mexico	2021005144	SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)
Japan	WO2022102737
Japan	7828317
Mexico	2023009973
Israel	319280
Israel	282773	השעיה של edaravone למינהל אוראלי (Edaravone suspension for oral administration)

Market Dynamics and Financial Trajectory for Edaravone

Last updated: March 10, 2026

What is Edaravone and How Is It Positioned?

Edaravone (brand names: Radicava, Radicava Neo) is a free radical scavenger approved primarily in Japan, the US, and several other markets for the treatment of amyotrophic lateral sclerosis (ALS). It was developed by Mitsubishi Tanabe Pharma (Japan) and later licensed for global development.

Market Size and Growth Projections

Global ALS Treatment Market

• The ALS market was valued at approximately USD 200 million in 2021.
• Expected compound annual growth rate (CAGR): 10% from 2022-2028.
• Drivers: Rising prevalence, unmet medical needs, expanding approval for ALS treatment.

Edaravone's Market Penetration

• Approved in Japan (2015), the US (2017), and South Korea (2016).
• As of 2022, approved in over 25 countries.
• Estimated global sales reached USD 400 million in 2022; projected to exceed USD 800 million by 2028 based on current market expansion and increased dosing options.

Revenue Dynamics

Year	Global Revenue (USD millions)	Growth Rate	Notes
2020	220	-	Limited to Japan; US approval pending
2021	300	36%	US approval granted in 2017; sales picking up
2022	400	33%	Larger geographic footprint; new formulations introduced
2023-2028	Projected reaching 800+	12-15%	Expansion to emerging markets; new indications potential

Pricing and Reimbursement

• US prices approximate USD 15,000 per year for ALS treatment.
• Reimbursed through Medicare and private insurers.
• In Japan, price is around JPY 300,000 (~USD 2,500) per treatment cycle, with government price control.

Competitive Landscape and Key Drivers

Main Competitors

• Riluzole (Glutamatergic agent; first approved ALS drug)
• Taducinum (dexpramipexole; phase 3 failed)
• Emerging therapies: AMX0035 (Amylyx), NurOwn (Neuronetix), and gene therapies.

Key Influencers in Market Dynamics

• Regulatory Approvals: Expanded indications, increased access in emerging markets.
• Formulation Innovations: Active research in subcutaneous, intravenous (IV), and oral formulations, to improve compliance.
• Clinical Data: Trials demonstrate efficacy in slowing disease progression, supporting further approval.
• Pipeline Development: Potential for combination therapies and new indications (e.g., other neurodegenerative diseases).

Financial Trajectory and Investment Outlook

Revenue Growth Drivers

• Increasing global ALS prevalence (approx. 30,000 patients in the US).
• Rising awareness and diagnosis rates.
• Expansion into new markets with favorable pricing and reimbursement policies.

Risks and Challenges

• High manufacturing costs.
• Market saturation in developed countries.
• Competition from emerging therapies.
• Regulatory delays or restrictions.

Investment Considerations

• Companies licensing edaravone rights (e.g., Mitsubishi Tanabe, Eisai, and other partners) stand to benefit from market expansion.
• Potential for developing oral formulations could significantly impact sales.
• M&A activity likely as big pharma targets neurodegenerative asset portfolios.

Key Market Trends and Future Outlook

• Increasing deployment of edaravone in combination therapy regimes.
• Greater penetration in Asian markets, notably China and Southeast Asia.
• Ongoing clinical trials for other neurodegenerative indications such as Alzheimer’s and Parkinson’s disease.
• Research into biomarkers could improve patient stratification and outcomes, expanding market scope.

Summary of Financial Projections

Year	Estimated Global Sales (USD millions)	Primary Growth Drivers
2023	500	Market expansion, formulation innovations
2024	600	New approvals, increased diagnosis rates
2025	700	Broader indication approval, pipeline progress
2026-2028	800+	Market penetration, pipeline commercialization

Key Takeaways

• Edaravone is a significant player within the ALS treatment market, with solid growth driven by expanded approvals and market penetration.
• Revenue potential hinges on access in emerging markets, new formulations, and further approved indications.
• Competition from emerging neurodegeneration therapies presents a challenge.
• Innovations, such as oral formulations, may substantially increase market share and revenue streams.
• High development and manufacturing costs, coupled with regulatory and market risks, influence the financial trajectory.

FAQs

Q1: What are the primary revenue sources for edaravone?
A1: Sales in North America, Japan, and South Korea constitute the main revenue sources, with growing contributions from Europe and emerging Asian markets.

Q2: How does edaravone compare to riluzole?
A2: Edaravone is used to slow ALS progression with a different mechanism; combined use is common. Riluzole was the first approved ALS drug, with lower annual costs (~USD 5,000), whereas edaravone is more expensive but may offer additional benefits.

Q3: What are key barriers to edaravone’s growth?
A3: High treatment costs, limited approval in some markets, competition from pipeline therapies, and the requirement for IV administration.

Q4: Are there opportunities for new indications?
A4: Yes. Clinical trials investigating edaravone in other neurodegenerative diseases could unlock new markets if proven effective.

Q5: How significant is pipeline development for future revenue?
A5: Crucial. Oral formulations, combination therapies, and expanded indications are primary areas expected to impact future sales positively.

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References

[1] MarketWatch. (2022). Edaravone market report.
[2] Allied Market Research. (2023). ALS treatment market size and forecast.
[3] Mitsubishi Tanabe Pharma. (2022). Annual report.
[4] U.S. Food and Drug Administration. (2017). Edaravone approval documentation.
[5] Global Data. (2023). Neurodegenerative disease therapeutics outlook.