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. Six 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
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Kk Bcj-94	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
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

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
Taiwan	202031256
China	112969459
Israel	319280
Denmark	3875085
Israel	282773	השעיה של edaravone למינהל אוראלי (Edaravone suspension for oral administration)
Singapore	11202104365Q

Market Dynamics and Financial Trajectory for Radicava ORS (Edaravone Orally Disintegrating Tablets)

Last updated: July 28, 2025

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Introduction

Radicava ORS (edaravone orodispersible tablets) represents an innovative development in the pharmaceutical landscape targeting amyotrophic lateral sclerosis (ALS). As the oral formulation of Radicava, developed by Mitsubishi Tanabe Pharma Corporation, Radicava ORS leverages the convenience of orally disintegrating tablets to improve patient adherence and expand market reach. Understanding the evolving market dynamics and financial trajectory of Radicava ORS is essential for stakeholders assessing its commercial potential within neurodegenerative disorder therapeutics.

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Market Landscape and Growth Drivers

Prevalence of ALS and Unmet Medical Needs

ALS is a progressive neurodegenerative disease with an estimated global prevalence of approximately 4.1 per 100,000 individuals, according to ALS Association data. The primary treatment, Radicava (edaravone), approved in the United States in 2017, offers symptomatic management but remains limited in disease-modifying capability. Growing awareness and earlier diagnosis underpin an expanding patient pool, especially in developed countries, fostering demand for more accessible treatment options such as Radicava ORS, approved by the FDA in 2022.

Advantages of Radicava ORS Over Intravenous Formulation

The original Radicava formulation requires intravenous infusion, often necessitating hospitalization or specialized outpatient management, which constrains accessibility and inflates healthcare costs. The ORS formulation simplifies administration, enabling patients to self-administer the medication, thereby reducing logistical barriers. This shift enhances treatment adherence, improves quality of life, and potentially broadens market penetration.

Regulatory and Market Expansion Opportunities

In addition to its approval in the U.S., Radicava ORS has received marketing authorization in several Asian markets, including Japan and South Korea, where ALS prevalence is notably higher. The flexible dosing regimen aligns with Japan’s healthcare policies favoring outpatient and home-based therapies, positioning Radicava ORS favorably in these markets. Ongoing regulatory pathways in Europe are poised to further expand access.

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Market Dynamics Influencers

Competitive Landscape

• Existing Therapies: Radicava faces competition primarily from Riluzole, the first FDA-approved ALS drug (1995), which offers modest survival benefits but has a long-standing market presence. Other emerging therapies, such as tofersen (antisense oligonucleotide), are under clinical evaluation.
• Potential Future Competitors: The pipeline includes novel neuroprotective agents and gene therapy approaches which could disrupt the space.
• Positioning of Radicava ORS: Its differentiator is improved administration. No direct oral equivalent of Radicava exists, giving Radicava ORS a competitive edge within its class.

Market Adoption and Reimbursement Policies

Market penetration depends heavily on clinician acceptance, patient preference, and reimbursement approvals. Positive real-world evidence and favorable payer policies expedite adoption. Mitsubishi Tanabe's strategic collaborations with payers and patient advocacy groups increase visibility and acceptance.

Pricing Strategy and Revenue Potential

Pricing of Radicava ORS is calibrated to reflect its convenience and therapeutic benefits. Premium pricing is possible given the unmet need and improved adherence. According to industry estimates, the drug's launch price in the U.S. is approximately $12,000 for a 28-day supply—similar to the intravenous form, adjusted for manufacturing and distribution costs.

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Financial Trajectory and Revenue Forecasts

Initial Market Penetration

In its first year post-launch, Radicava ORS's sales are projected to be modest, aligning with the limited patient base and competitive factors. Industry analysts forecast global sales reaching $200–300 million within the first five years, driven by expanding indications and geographic reach.

Growth Trajectory Factors

1. Market Penetration Rate: As awareness grows and reimbursement stabilizes, adoption is expected to accelerate.
2. Geographic Expansion: Entry into European markets and ongoing approvals in Latin America and other regions will bolster revenues.
3. Pipeline Synergies: Radicava's overall portfolio, including clinical trials for other neurodegenerative diseases, could create synergistic growth opportunities.
4. Pricing and Regulatory Outcomes: Favorable pricing negotiations and accelerated approvals could enhance revenue streams.

Key Financial Risks

• Market Size Limitations: Limited ALS prevalence constrains upside.
• Competition: Emergence of novel therapies could cannibalize sales.
• Regulatory Challenges: Variations in approval processes and reimbursement policies across countries pose risks.
• Manufacturing Scalability: Ensuring a consistent supply of high-quality ORS formulation is critical for revenue stability.

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Strategic Outlook and Long-term Prospects

Radicava ORS is positioned as a disruptive product within ALS therapeutics due to its ease of administration. Its financial trajectory hinges on successful adoption, expanding indications, and geographic expansion, coupled with strategic pricing and reimbursement agreements.

In the broader context, the increasing focus on neurodegenerative disorder management and patient-centric formulations signals sustained demand for oral therapies like Radicava ORS. Long-term growth prospects are positive but contingent upon overcoming legal, regulatory, and competitive hurdles.

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Key Takeaways

• Radicava ORS leverages formulation innovation to expand ALS treatment accessibility, directly impacting market dynamics.
• The global ALS burden and need for outpatient-friendly therapies bolster market potential.
• Competitive advantages stem from improved convenience and patient adherence, positioning Radicava ORS favorably against intravenous formulations.
• Revenue growth will be driven by geographic expansion, increased market penetration, and favorable reimbursement frameworks.
• Risks include limited disease prevalence, emerging competitors, and regulatory complexities.

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FAQs

1. What distinguishes Radicava ORS from the intravenous formulation?
Radicava ORS offers a convenient, orally disintegrating tablet form that eliminates the need for infusion, enhancing patient convenience and adherence.

2. Which markets have authorized Radicava ORS?
Currently, Radicava ORS is approved in the United States, Japan, and South Korea, with additional approvals anticipated in Europe and other regions.

3. How does Radicava ORS's pricing compare with the intravenous form?
Pricing is expected to be similar per treatment cycle, reflecting the convenience premium, with potential discounts or negotiated prices varying by healthcare system.

4. What are the primary factors influencing Radicava ORS's market adoption?
Physician awareness, patient preference, reimbursement policies, and real-world evidence establishing efficacy significantly impact adoption.

5. What is the long-term revenue outlook for Radicava ORS?
Projected to reach several hundred million dollars globally within five years, contingent upon geographic expansion, market acceptance, and pipeline developments.

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References

1. ALS Association. (2022). Prevalence and Epidemiology.
2. Mitsubishi Tanabe Pharma Corporation. (2022). Radicava (edaravone) orodispersible tablets approval updates.
3. FDA. (2022). Radicava ORS approval announcement.
4. Industry Reports. (2023). Global ALS Therapeutics Market Analysis.
5. MarketWatch. (2023). Drug Pricing and Reimbursement Trends.