RADICAVA Drug Patent Profile

Which patents cover Radicava, and what generic alternatives are available?

Radicava is a drug marketed by Mitsubishi Tanabe and Kk Bcj-94 and is included in two NDAs. There are eight patents protecting this drug.

The generic ingredient in RADICAVA is edaravone. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Radicava

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

Summary for RADICAVA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	5
Patent Applications:	3,681
Drug Prices:	Drug price information for RADICAVA
What excipients (inactive ingredients) are in RADICAVA?	RADICAVA excipients list
DailyMed Link:	RADICAVA at DailyMed

See drug prices for RADICAVA

Recent Clinical Trials for RADICAVA

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

Sponsor	Phase
Oliver Blanchard	PHASE2
Université de Montréal	PHASE2
Auzone Biological Technology Pty Ltd	Phase 1

See all RADICAVA clinical trials

US Patents and Regulatory Information for RADICAVA

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	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017		DISCN	Yes	No
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	12,285,409		Y
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	12,194,025
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	11,241,416		Y
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018	AP	RX	Yes	No

Expired US Patents for RADICAVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017	6,933,310
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018	6,933,310

International Patents for RADICAVA

See the table below for patents covering RADICAVA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1405637	MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS))
Austria	303808
Japan	3758164
Japan	WO2002034264	筋萎縮性側索硬化症（ＡＬＳ）治療剤
World Intellectual Property Organization (WIPO)	0234264
Germany	60022560

Market Dynamics and Financial Trajectory for RADICAVA

Last updated: July 27, 2025

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Introduction

RADICAVA (edaravone) has established itself as a pivotal therapeutic avenue in the management of amyotrophic lateral sclerosis (ALS). Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, RADICAVA's market trajectory demonstrates significant shifts driven by regulatory, clinical, and commercial factors. This analysis explores the underlying market dynamics, revenue potential, competitive landscape, and future prospects shaping RADICAVA’s financial outlook.

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Regulatory Landscape and Market Entry

RADICAVA received FDA approval for ALS in 2017 based on clinical evidence demonstrating reduced oxidative stress, a key pathogenic mechanism in ALS. The drug’s initial approval came with designations such as Breakthrough Therapy and Orphan Drug, expediting its market entry amid significant unmet clinical needs. Subsequent approvals in other markets, including Japan (2018) and the European Union (2018 via conditional marketing authorization), expanded its geographic footprint.

Regulatory approvals serve as catalysts, influencing market penetration and prescribing behavior. Notably, the FDA’s decision was reinforced by positive Phase III trial data, positioning RADICAVA as a differentiated candidate versus off-label management options. The regulatory pathway's designations have also provided incentives for ongoing R&D investment, critical in maintaining competitive advantage.

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Market Dynamics

Demand Drivers

• Unmet Medical Need: ALS remains a devastating, progressive neurodegenerative disorder with limited treatment options. RADICAVA’s approval addressed a significant therapeutic gap, propelling demand.
• Clinical Efficacy: The drug demonstrated a modest yet meaningful slowing of disease progression, translating into improved survival metrics. This clinical benefit underpinning the approval fuels ongoing clinician and patient interest.
• Post-Approval Uses: Expansion into early-stage ALS and combination therapy research could elevate demand further.

Competitive Landscape

RADICAVA’s primary competition stems from Riluzole, approved since 1995, and more recently, AMX0035 (ternespirelsen and phenylbutazone), which gained FDA approval in 2022. While riluzole’s efficacy is well established, RADICAVA’s distinct mechanism offers a competitive edge in specific patient populations.

Biotech firms exploring neuroprotective agents and other symptomatic therapies threaten to erode RADICAVA’s market share over time. Yet, the absence of highly effective treatments preserves RADICAVA’s niche position in the short term.

Pricing and Reimbursement

Pricing strategies heavily influence RADICAVA's revenues. The drug’s annual therapy cost in the U.S. hovers around $150,000—substantial for a rare disease. Payer negotiations, patient assistance programs, and inclusion in clinical guidelines profoundly impact access and sales.

In addition, health technology assessments (HTAs) in markets like Europe influence reimbursement decisions, with some agencies expressing caution over clinical benefit magnitude against cost.

Supply Chain and Manufacturing

Complex manufacturing, owing to its intravenous formulation, warrants sophisticated logistics and quality control. Supply chain disruptions, as seen during the COVID-19 pandemic, temporarily impacted availability, potentially affecting sales.

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Financial Trajectory and Revenue Potential

Historical Revenue Trends

Since its launch, RADICAVA’s sales have grown steadily, supported by its orphan drug designation and expanded indications. According to Eisai's fiscal reports, U.S. sales in 2021 approached $245 million, with international sales contributing further. The drug's revenue growth reflects an expanding patient base, increased market awareness, and supportive regulatory environments.

Forecasting Future Revenues

Market analysts project continued growth, driven by:

• Increased diagnosis rates: As awareness improves, earlier detection of ALS will expand the accessible patient pool.
• Regulatory approvals in additional territories: Countries like China may open new revenue channels.
• Expansion into combination therapy programs: Emerging clinical trials exploring synergistic regimens could extend sales lifecycles.
• Market penetration in early-stage ALS: Clinical trials suggest potential approval pathways, increasing eligible patients.

Estimating conservative CAGR (Compound Annual Growth Rate) of 8-10%, revenues could surpass $500 million globally by 2027, accounting for increased access and potential label expansions.

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Challenges and Risks

• Clinical Limitations: The modest efficacy margin raises questions on long-term treatment value and pricing leverage.
• Pricing Pressures: Payers’ increasing scrutiny could reduce reimbursement levels.
• Competition from Emerging Therapies: New drugs may improve upon RADICAVA's efficacy, eroding market share.
• Manufacturing and Supply Risks: Any disruption could negatively impact sales.

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Strategic Opportunities

• Indication Expansion: Pursuing approvals for earlier ALS stages or other neurodegenerative indications.
• Combination Therapy Development: Enhancing clinical outcomes through adjunct therapies.
• Geographic Expansion: Targeting emerging markets with rising healthcare infrastructure investment.
• Patient Access Programs: Innovating pricing strategies to expand patient reach amid price sensitivity.

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Conclusion

RADICAVA’s market dynamics are characterized by strong unmet medical need, regulatory momentum, and strategic positioning within niche ALS treatment. Financial growth prospects are promising but constrained by clinical efficacy margins and competitive pressures. Ongoing R&D, geographic expansion, and evolving reimbursement strategies will be pivotal in shaping a sustainable revenue trajectory. As ALS remains a high unmet need, RADICAVA’s role as a differentiator will likely preserve or enhance its market footprint in the coming years.

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Key Takeaways

• Market Expansion: Regional and indication expansions are critical to sustain revenue growth.
• Pricing and Reimbursement: Negotiations and patient access programs directly influence future sales potential.
• Clinical Development: Demonstrating significant efficacy benefits can elevate RADICAVA’s competitive position.
• Competitive Landscape: Monitoring emerging therapies is essential as new treatment modalities threaten market share.
• Regulatory Strategy: Continued engagement with regulators for label extensions can unlock new markets and maximize drug value.

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FAQs

1. What are the primary factors driving RADICAVA’s sales growth?
Demand for effective ALS treatment, regulatory approvals in multiple jurisdictions, and expanding indications contribute primarily. Increasing awareness and advances in diagnosis also expand the patient base.

2. How does RADICAVA compare to its main competitor Riluzole?
RADICAVA offers a distinct mechanism of action and has demonstrated a modest but statistically significant slowing of disease progression, whereas riluzole has a longer-standing clinical track record. Combining therapies may offer additive benefits.

3. What are the key regulatory hurdles for RADICAVA’s future expansion?
Obtaining approvals for earlier disease stages or additional neurodegenerative disorders requires robust clinical data demonstrating meaningful benefits, which remains challenging given the disease's complexity.

4. How does pricing influence RADICAVA’s market accessibility?
High treatment costs limit access; payers require evidence of cost-effectiveness. Patient assistance programs are vital in mitigating financial barriers.

5. What is the prognosis for RADICAVA’s market longevity?
While current growth projections are positive, competition from newer agents, clinical efficacy limitations, and payer pressures could define the drug’s lifecycle. Ongoing innovation and expansion strategies are essential for sustained success.

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Sources

[1] Eisai Inc. Fiscal Year Reports, 2021.
[2] U.S. Food and Drug Administration (FDA). RADICAVA Approval Documentation, 2017.
[3] European Medicines Agency (EMA). Conditional Marketing Authorization for RADICAVA, 2018.
[4] Market research reports on ALS therapeutics, 2022.