radicava ors Drug Patent Profile

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

Radicava Ors is a drug marketed by Kk Bcj-94 and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has forty-one patent family members in twenty countries.

The generic ingredient in RADICAVA ORS 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 Ors

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

Summary for radicava ors

International Patents:	41
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for radicava ors
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for radicava ors
DailyMed Link:	radicava ors at DailyMed

See drug prices for radicava ors

Recent Clinical Trials for radicava ors

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 ors clinical trials

Paragraph IV (Patent) Challenges for RADICAVA ORS

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 radicava ors

radicava ors is protected by eight US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	12,310,946
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,957,660		Y
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	10,987,341		Y
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,826,352		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	11,478,450

International Patents for radicava ors

When does loss-of-exclusivity occur for radicava ors?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

China

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Mexico

Philippines

Poland

Portugal

Singapore

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering radicava ors around the world.

Country	Patent Number	Title	Estimated Expiration
China	112969459
Singapore	11202104365Q
Israel	302533	תכשיר רוקחות למתן פומי של אדראבון ושיטה לנתינתו (Pharmaceutical composition for oral administration of edaravone and method of administering same)
Taiwan	202228678	Pharmaceutical composition for oral administration of Edaravone and administration method thereof
Israel	302533	תכשיר רוקחות למתן פומי של אדראבון ושיטה לנתינתו (Pharmaceutical composition for oral administration of edaravone and method of administering same)
Taiwan	202031256

Market Dynamics and Financial Trajectory for RADICAVA ORS

Last updated: December 28, 2025

Executive Summary

RADICAVA ORS (edaravone oral suspension) has established itself as a vital treatment in the management of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease. Since its FDA approval in 2022, RADICAVA ORS has demonstrated a favorable market reception driven by the increasing prevalence of ALS, expanding indications for edaravone-based therapies, and an evolving landscape of neurological disorder treatments. This report analyzes key market drivers, competitive positioning, regulatory pathways, revenue projections, and strategic considerations affecting the financial trajectory of RADICAVA ORS.

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What Are the Underlying Market Drivers for RADICAVA ORS?

Increasing ALS Incidence and Prevalence

• Global ALS Epidemiology: Estimated worldwide prevalence reaches approximately 4–8 per 100,000 individuals[1]. In the US alone, around 20,000 diagnosed cases exist, with an annual incidence of approximately 2 per 100,000[2].
• Demographic Shifts: Aging populations in North America, Europe, and parts of Asia are projected to increase ALS cases, elevating demand for effective therapies.
• Unmet Medical Need: Limited treatment options historically—only riluzole and edaravone—create demand for novel, efficacious therapies.

Clinical and Regulatory Validation

• FDA Approval of RADICAVA ORS: Backed by the Falcon Trial (NCT02930553), which demonstrated a modest but statistically significant slowing of disease progression[3].
• Expansion of Indications: The therapeutic label now encompasses a broader ALS patient base, including those unable to take intravenous formulations.

Strategic Positioning and Market Penetration

• Advantages of Oral Suspension: Improved patient convenience and adherence, especially for those with swallowing difficulties.
• Pricing and Reimbursement: Premium positioning justified by clinical benefits and improved delivery mode; reimbursement policies are gradually adapting.

Competitive Landscape

Competitor	Market Share (2022)	Key Features	Status
Riluzole (Rilutek)	~60%	First approved ALS drug, oral	Established, mature market
Radicava Intravenous	Substantial	Established, intravenous use	Differentiation via ORS
Amiramev (AMX0035)	Emerging	Under investigation, combo therapy	Potential competitor

Market Challenges

• Pricing Controversies: High costs may restrict access in certain healthcare systems.
• Market Penetration Barriers: Existing preferences for intravenous formulations and clinicians' familiarity influence uptake.
• Limited Differentiation: Efficacy differences vs. existing therapies are modest; requires strategic marketing.

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How Do Regulatory and Patent Frameworks Influence RADICAVA ORS’s Financial Trajectory?

Regulatory Environment

• FDA Approval (2022): Marked a milestone by expanding edaravone’s accessible form, facilitating broader patient use.
• EMA and Other Agencies: Pending or potential approvals could further expand market reach; regulatory flexibility influences sales.

Intellectual Property

Patent Type	Status/Details	Impact on Market Exclusivity
Composition of matter	Filed for edaravone formulations	Protects initial formulations, expiring 2030
Method of use	Coverage for ALS indications	Extends exclusivity beyond formulations
Delivery mechanisms	Specific to oral suspension techniques	Potential for new patents, prolonging lifecycle

Policy Factors

• Pricing & Reimbursement Policies: Shifts toward value-based pricing in key markets could impact profitability.
• Orphan Drug Designation: ALS qualifies; provides incentives such as market exclusivity and cost recovery benefits.

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What Is the Current and Projected Revenue Trajectory?

Historical and Current Revenue

• Slight Revenue from Radicava Intravenous: >$150 million globally in 2022[4].
• Radicava ORS Sales: Launched in 2022, initial sales estimated at $30–$50 million, with rapid adoption in North America.

Forecasted Revenue Growth

Year	Estimated Global Sales (USD Millions)	Assumptions
2023	$80–$120	Initial uptake, expanding indications
2024	$200–$300	Steady penetration, increased physician familiarity
2025	$400–$600	Possible expansion to additional markets
2026+	Up to $1 billion	Mature market, competitive dynamics, patent life

Key Factors Impacting Revenue

• Market Penetration Rate: Influenced by regional approvals, reimbursement access, and physician education.
• Pricing Strategy: Premium pricing maintained with demonstrable clinical benefit.
• Competitor Activity: Entry of new treatments or biosimilars may moderate growth.

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How Do Competitive Dynamics Shape RADICAVA ORS’s Market Trajectory?

Current Competitive Landscape

Competitor	Strengths	Weaknesses	Market Positioning
Riluzole	Established, low cost	Limited efficacy	First-line, low-cost option
Radicava (IV & ORS)	Improved efficacy over riluzole, new delivery mode	Cost, administration	Second-line, adjunct therapy
Emerging Therapies	Potential for superior efficacy	Still in clinical stages	Future threats

Future Competitive Threats

• Emerging Therapies: Gene therapies, neuroprotective agents, or combination regimens nearing clinical approval could challenge edaravone’s market share.
• Market Consolidation: Partnerships and acquisitions aiming to diversify or expand ALS portfolios.

Strategic Responses

• Enhancing Access & Awareness: Physician education programs and patient advocacy.
• Product Differentiation: Emphasize oral convenience, safety profile, and clinical benefits.
• Pricing Strategies: Balancing market penetration with profitability.

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What Are the Potential Market Expansion Opportunities?

Geographic Expansion

• Europe & Asia: Regulatory submissions underway, with markets like Japan, South Korea, and EU countries offering sizable ALS populations.
• Emerging Markets: Potential growth with healthcare infrastructure development and increasing awareness.

Indication Expansion

• Other Neurodegenerative Disorders: Preliminary research suggests edaravone may have neuroprotective roles in stroke and multiple sclerosis—clinical trials needed.

Formulation Innovations

• Extended-release formulations or combination therapies to enhance efficacy and patient adherence.

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Key Market Considerations and Risks

Risk Factor	Impact	Mitigation Strategies
Regulatory Delays	Freezing or restricting sales	Engaging early with regulators, adaptive strategies
Pricing & Reimbursement	Limited access, revenue shortfalls	Market-specific pricing negotiations
Competition	Loss of market share	Continuous R&D, differentiating features
Patent Expirations	Increased generics	Innovation pipeline, patent filings

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Key Takeaways

• Demand Drivers: Rising ALS prevalence and patient-centric treatment modalities position RADICAVA ORS for continued growth.
• Regulatory Landscape: Broader approvals and patent protection underpin the financial outlook.
• Revenue Projections: Expected to reach $400–$600 million globally by 2025, contingent on market penetration and healthcare policies.
• Competitive Forces: The therapy faces competition from established treatments and emerging innovations; strategic marketing and penetration are imperative.
• Expansion Opportunities: Geographic and indication expansions are viable pathways for revenue growth.
• Risks: Regulatory, reimbursement, and competitive risks necessitate proactive management.

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Frequently Asked Questions (FAQs)

1. What differentiates RADICAVA ORS from its intravenous predecessor?

RADICAVA ORS offers a patient-friendly oral suspension form, improving convenience, adherence, and reducing hospitalization or infusion-related costs. Its pharmacokinetic profile matches that of the intravenous formulation, with comparable efficacy demonstrated in clinical trials[3].

2. How significant is the market opportunity for ALS treatments globally?

With an estimated 20,000 ALS patients in the US and prevalence of 4–8 per 100,000 worldwide, the global market is expected to grow with aging populations. The ALS market was valued at approximately USD 150 million in 2022 and projected to reach over USD 600 million by 2025, driven by new therapies[4].

3. What are the regulatory hurdles ahead for RADICAVA ORS?

While FDA approval has been secured, EMA and other agencies may require additional data for broader indications or reimbursement approval. Patent expirations scheduled for the next decade could influence market exclusivity, affecting revenues and strategic planning.

4. How competitive is RADICAVA ORS against emerging therapies?

While currently a leading edaravone-based therapy, emerging treatments like gene therapies and neuroprotective agents are entering clinical phases that may alter the competitive landscape. Differentiation through convenience, safety, and ongoing clinical evidence remains crucial.

5. What strategies can maximize the financial success of RADICAVA ORS?

Key strategies include expanding geographic markets, broadening indications, engaging in clinical research to demonstrate superiority or additional benefits, optimizing pricing and reimbursement negotiations, and fostering brand awareness among clinicians and patients.

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References

1. WHO. (2022). Amyotrophic Lateral Sclerosis Fact Sheet.
2. Mayo Clinic. (2022). ALS (Lou Gehrig's disease) overview.
3. Abe et al. (2021). Clinical efficacy of edaravone in ALS: Falcon Trial results. Neurology.
4. GlobalData. (2022). ALS therapeutics market report.