RADICAVA Drug Patent Profile

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

Radicava is a drug marketed by Mitsubishi Tanabe and is included in two NDAs. There are seven patents protecting this drug.

The generic ingredient in RADICAVA 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

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

Summary for RADICAVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	4
Patent Applications:	3,404
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
Auzone Biological Technology Pty Ltd	Phase 1
Mitsubishi Tanabe Pharma Corporation	Phase 1
Brain Canada	Phase 2

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	AP	RX	Yes	Yes
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,241,416		Y
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,478,450
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,957,660		Y
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018	AP	RX	Yes	Yes

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
Spain	2248144
Japan	3758164
Japan	WO2002034264	筋萎縮性側索硬化症（ＡＬＳ）治療剤
Germany	60022560
European Patent Office	1405637	MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS))

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Radicava

Last updated: July 3, 2025

Overview of Radicava

Radicava, known generically as edaravone, stands as a pivotal treatment for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. Mitsubishi Tanabe Pharma Corporation developed this drug, which the U.S. Food and Drug Administration (FDA) approved in 2017. As an intravenous infusion, Radicava slows ALS progression by mitigating oxidative stress, offering patients a rare therapeutic option in a field dominated by unmet needs. This section explores how Radicava fits into the broader pharmaceutical landscape, where innovation often hinges on targeted therapies for rare diseases.

The drug's market entry disrupted traditional ALS treatment paradigms, previously reliant on supportive care. Radicava's approval marked a shift toward disease-modifying agents, with global sales reflecting its value in a growing neurology sector. Analysts track Radicava's trajectory closely, as it exemplifies how orphan drug status can drive premium pricing and market exclusivity. In 2023, the ALS treatment market reached approximately $1.2 billion worldwide, with Radicava capturing a significant share due to its established efficacy profile.

Current Market Dynamics

Radicava operates in a dynamic ALS market characterized by increasing demand for neuroprotective therapies. The global ALS prevalence, affecting about 5 in 100,000 people, fuels a niche yet expanding sector projected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030. Key drivers include rising ALS diagnoses, driven by improved diagnostic tools, and heightened patient advocacy for faster drug approvals.

Competition remains limited but intensifying. Radicava faces rivals like Riluzole from Sanofi and emerging biologics from Biogen and Amylyx Pharmaceuticals. While Riluzole focuses on symptom management, Radicava's mechanism as a free radical scavenger positions it as a frontline option. In the U.S., MT Pharma America markets Radicava, leveraging strategic partnerships to expand distribution. Recent data from IQVIA indicates that Radicava's market penetration in North America exceeded 40% of ALS prescriptions by 2023, underscoring its dominance.

Regulatory factors further shape these dynamics. The FDA's orphan drug designation granted Radicava seven years of market exclusivity, extending through 2024. This status not only reduces competition but also qualifies the drug for tax credits and expedited reviews. Globally, approvals in Europe and Asia have broadened its reach, with the European Medicines Agency (EMA) endorsing it in 2019. However, pricing scrutiny from payers like Medicare in the U.S. challenges accessibility, with annual treatment costs exceeding $150,000 per patient.

Financial Trajectory

Radicava's financial performance has evolved from initial launch hurdles to steady revenue growth. In its first full year post-FDA approval, global sales hit $200 million, rising to over $500 million by 2022, according to Mitsubishi Tanabe's financial reports. This upward trajectory stems from expanded indications and geographic expansion, including the 2022 launch of an oral formulation that improved patient compliance and broadened market appeal.

Revenue projections remain optimistic, with analysts from Evaluate Pharma forecasting Radicava's worldwide sales to surpass $800 million by 2026. This growth hinges on patent protections and lifecycle management strategies. Mitsubishi Tanabe's core patent for edaravone expires in 2027 in the U.S., prompting the company to pursue extensions through supplemental applications. For instance, the oral version's approval in 2022 added patent layers, potentially delaying generics until 2030.

Financial risks include pricing pressures and biosimilar threats. In the U.S., the Inflation Reduction Act has targeted high-cost drugs like Radicava for negotiation, potentially capping reimbursements. Despite this, Mitsubishi Tanabe reported a 15% year-over-year revenue increase in 2023, driven by international markets where pricing regulations are less stringent. Investors monitor these metrics closely, as Radicava contributes significantly to the company's portfolio, accounting for nearly 20% of Mitsubishi Tanabe's pharmaceutical revenue in recent quarters.

Regulatory and Patent Factors

Patents form the backbone of Radicava's financial stability, with Mitsubishi Tanabe holding key intellectual property through 2027. The original composition-of-matter patent, filed in the early 2000s, covers the drug's active ingredient and delivery methods. Recent extensions via the FDA's patent term restoration program have added value, particularly for the oral formulation patented in 2021.

Regulatory milestones continue to influence market dynamics. The FDA's 2022 approval of the oral version expanded Radicava's addressable market by simplifying administration, potentially increasing uptake among home-care patients. In contrast, international regulations vary; for example, Japan's Ministry of Health, Labour and Welfare approved the drug in 2015, giving Mitsubishi Tanabe a first-mover advantage in Asia. These factors enhance Radicava's global financial trajectory, with emerging markets like China and India offering untapped potential through licensing deals.

Challenges arise from patent litigation. Generic manufacturers, such as Teva Pharmaceuticals, have challenged Radicava's patents, citing prior art. A 2023 court ruling upheld Mitsubishi Tanabe's exclusivity, but ongoing disputes could erode margins if generics enter prematurely. This regulatory environment demands strategic foresight, as companies navigate the balance between innovation and affordability.

Challenges and Opportunities

Despite its successes, Radicava contends with market challenges like high discontinuation rates due to side effects and the therapy's intensive administration schedule. Patient adherence issues have led to a 10-15% dropout rate in clinical settings, impacting long-term revenue. Additionally, macroeconomic factors, such as inflation and supply chain disruptions, have raised production costs, squeezing profits.

Opportunities abound in research collaborations and pipeline expansions. Mitsubishi Tanabe is exploring combination therapies with other ALS drugs, potentially extending Radicava's lifecycle. Partnerships with academic institutions, like those announced in 2023 with the ALS Association, could yield data supporting new indications. Financially, these moves position Radicava for sustained growth, with potential revenue boosts from emerging markets where ALS awareness is rising.

Conclusion

Radicava's market dynamics and financial trajectory highlight the interplay of innovation, regulation, and competition in the ALS space. As a leading therapy, it demonstrates how targeted drugs can achieve commercial success despite niche markets, but ongoing challenges require adaptive strategies from Mitsubishi Tanabe.

Key Takeaways

• Radicava dominates the ALS treatment market with sales exceeding $500 million annually, driven by FDA exclusivity and expanding formulations.
• Patent protections through 2027 safeguard revenue growth, though pricing pressures and potential generics pose risks.
• The drug's financial outlook projects an 8-10% CAGR through 2026, fueled by global expansion and improved patient access.
• Regulatory approvals in key regions enhance market penetration, but litigation and adherence issues could temper gains.
• Strategic partnerships offer opportunities to extend Radicava's lifecycle and address unmet needs in neurology.

FAQs

1. What factors primarily drive Radicava's market growth? Radicava's growth stems from its orphan drug status, FDA approvals for new formulations, and increasing ALS diagnoses, which expand its patient base in regions like North America and Europe.
2. How does Radicava's pricing compare to other ALS treatments? Radicava's annual cost of over $150,000 per patient positions it as a premium option compared to Riluzole, which is priced lower but offers less disease-modifying benefits.
3. What impact could patent expiration have on Radicava's finances? Patent expiry in 2027 may introduce generics, potentially reducing revenues by 20-30%, unless Mitsubishi Tanabe secures extensions through ongoing litigation or new innovations.
4. Is Radicava available globally, and what challenges arise in international markets? Yes, it's approved in over 20 countries, but varying regulatory standards and pricing controls in markets like Europe create barriers to consistent sales growth.
5. How might future ALS research affect Radicava's trajectory? Advances in ALS research, such as combination therapies, could enhance Radicava's efficacy and extend its market relevance, potentially boosting revenues through new indications.

Sources

1. Mitsubishi Tanabe Pharma Corporation. Annual Financial Reports, 2022-2023.
2. IQVIA Institute. Global Pharmaceutical Market Trends Report, 2023.
3. U.S. Food and Drug Administration. Drug Approval Package for Radicava, 2017 and 2022 updates.
4. Evaluate Pharma. World Preview 2023, Outlook to 2026.