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 Mitsubishi Tanabe and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven 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:	37
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
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
Auzone Biological Technology Pty Ltd	Phase 1
Mitsubishi Tanabe Pharma Corporation	Phase 1
Brain Canada	Phase 2

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 six 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
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	12,194,025
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		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
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	10,987,341		Y
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	11,826,352		Y

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
Japan	WO2020091036
China	117398346
Mexico	2024000663	SUSPENSION DE EDARAVONA PARA ADMINISTRACION ORAL. (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION.)
China	116761601
Taiwan	202031256
Israel	282773
Japan	2023087011	経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)

Market Dynamics and Financial Trajectory for RADICAVA ORS

Introduction

RADICAVA ORS, an oral suspension formulation of edaravone, has been a significant development in the treatment of amyotrophic lateral sclerosis (ALS). Approved by the U.S. Food and Drug Administration (FDA) in May 2022, this drug has marked a new era in ALS treatment, offering patients a more convenient and less burdensome alternative to the intravenous formulation.

Approval and Launch

The approval of RADICAVA ORS in the United States, followed by approvals in Canada and Japan, has been a crucial milestone. This oral formulation was developed to address the challenges associated with the intravenous administration of RADICAVA, which required patients to undergo daily infusions for 14 consecutive days, followed by a two-week drug-free period[3].

Market Impact

Sales Performance

Since its launch, RADICAVA ORS has shown strong sales performance. In the first half of the fiscal year 2023, sales of RADICAVA ORS in North America continued to be robust, contributing significantly to the growth in the health care segment. The revenue from RADICAVA ORS increased by 8%, and the core operating income rose by 7.2 times compared to the previous year[1].

Competitive Landscape

The ALS treatment landscape has evolved significantly with the introduction of RADICAVA ORS. This drug has filled a critical gap by offering an oral formulation that is more patient-friendly compared to the intravenous version. The market has responded positively, with projected revenues of USD 900 million by 2034 across major markets, according to DelveInsight[4].

Financial Trajectory

Revenue Growth

The financial performance of RADICAVA ORS has been impressive. The drug's sales have been a key driver of revenue growth for Mitsubishi Tanabe Pharma America. In the fiscal year ended March 31, 2023, the health care segment saw a significant increase in sales revenue and core operating income, largely due to the steady sales of RADICAVA ORS and other priority products[2].

Core Operating Income

The core operating income from the health care segment, which includes RADICAVA ORS, rose substantially. For the fiscal year 2023, the core operating income in the health care segment was expected to increase by JPY 38 billion from the initial forecast, reflecting the strong performance of RADICAVA ORS sales in North America[1].

Cost Structure and Efficiency

The transition to the oral formulation has also led to cost structure improvements. Patients no longer need to visit hospitals for intravenous injections, reducing healthcare resource utilization and costs. This shift has not only improved patient outcomes but also optimized healthcare delivery, as highlighted by Mitsubishi Tanabe Pharma America's data presented at the Academy of Managed Care Pharmacy (AMCP) 2024[5].

Clinical Efficacy and Patient Outcomes

Clinical Studies

Recent studies presented at the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2024 Annual Meeting have reinforced the efficacy of RADICAVA ORS. A Phase 3b extension study confirmed that the FDA-approved on/off regimen of RADICAVA ORS is the most appropriate dosing schedule for patients with ALS. The study also showed that treatment with RADICAVA ORS increased survival outcomes and decreased physical function decline compared to historical placebo controls[3].

Patient Benefits

The oral formulation of RADICAVA ORS has significantly relieved the burden on patients and their families. Unlike the intravenous version, which required hospital visits, RADICAVA ORS can be taken orally at home, making treatment more manageable and less cumbersome[1].

Regulatory and Market Recognition

FDA Recognition

In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity, acknowledging its major contribution to patient care through its innovative oral formulation. This recognition underscores the drug's significance in the ALS treatment landscape[3].

Global Expansion

While the launch in the United States, Canada, and Japan has been successful, the prospects for launch in Europe remain uncertain. However, the strong performance in existing markets suggests a promising future for RADICAVA ORS globally[4].

Challenges and Future Outlook

Market Competition

Despite its strong performance, RADICAVA ORS faces competition from other treatments and potential generics. The introduction of RADICUT generics in Japan, for example, has impacted the sales of the intravenous formulation of RADICAVA[4].

Economic Value

The economic value of RADICAVA ORS is a critical factor in its market dynamics. The drug's ability to improve efficiency and reduce healthcare costs is a significant advantage. Mitsubishi Tanabe Pharma America continues to emphasize the economic and clinical benefits of RADICAVA ORS, which is expected to drive its adoption and revenue growth[5].

Key Takeaways

• Strong Sales Performance: RADICAVA ORS has shown robust sales growth since its launch, particularly in North America.
• Financial Impact: The drug has significantly contributed to the revenue and core operating income of Mitsubishi Tanabe Pharma America.
• Clinical Efficacy: Studies have confirmed the efficacy of RADICAVA ORS in improving survival outcomes and reducing physical function decline in ALS patients.
• Patient Benefits: The oral formulation has eased the treatment burden on patients and their families.
• Regulatory Recognition: FDA recognition with Orphan Drug Exclusivity highlights the drug's innovative contribution to ALS treatment.
• Global Prospects: While European launch prospects are uncertain, the drug's performance in existing markets is promising.

FAQs

What is RADICAVA ORS, and how is it different from the intravenous formulation?

RADICAVA ORS is an oral suspension formulation of edaravone, approved for the treatment of ALS. Unlike the intravenous formulation, it can be taken orally at home, reducing the need for hospital visits and making treatment more manageable.

How has RADICAVA ORS performed in terms of sales since its launch?

Since its launch, RADICAVA ORS has shown strong sales performance, particularly in North America, contributing significantly to the revenue and core operating income of Mitsubishi Tanabe Pharma America.

What are the clinical benefits of RADICAVA ORS compared to historical treatments?

Studies have shown that RADICAVA ORS improves survival outcomes and reduces physical function decline in ALS patients compared to historical placebo controls.

How does RADICAVA ORS impact healthcare costs and resource utilization?

RADICAVA ORS has been shown to improve efficiency and reduce healthcare costs by eliminating the need for hospital visits for intravenous infusions.

What is the projected revenue for RADICAVA ORS by 2034?

According to DelveInsight, the projected revenue for RADICAVA ORS by 2034 is USD 900 million across major markets.

Is RADICAVA ORS available globally, or are there any regions where its launch is uncertain?

While RADICAVA ORS has been approved and launched in the United States, Canada, and Japan, its launch in Europe remains uncertain.

Sources

1. Mitsubishi Chemical Group Corporation, "Presentation: H1 Results for FY2023," November 1, 2023.
2. Mitsubishi Chemical Group Corporation, "Consolidated Financial Results for the Fiscal Year Ended March 31, 2023," May 12, 2023.
3. Mitsubishi Tanabe Pharma America, "Mitsubishi Tanabe Pharma America Presents New Results of RADICAVA ORS (Edaravone) from a Phase 3b Efficacy and Safety Extension Study and a Clinical Analysis of Multiple Studies at NEALS 2024," October 21, 2024.
4. DelveInsight, "Evolving Treatment Landscape of Amyotrophic Lateral Sclerosis," September 24, 2024.
5. Mitsubishi Tanabe Pharma America, "Mitsubishi Tanabe Pharma America to Present Healthcare Resource Utilization Data in RADICAVA ORS (Edaravone)-Treated ALS Patients at AMCP 2024," April 15, 2024.