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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 five 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:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	4
Patent Applications:	2,579
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
University of Calgary	Phase 2

See all RADICAVA clinical trials

US Patents and Regulatory Information for RADICAVA

RADICAVA is protected by zero 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	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	11,826,352		Y
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

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
Spain	2248144
Japan	WO2002034264	筋萎縮性側索硬化症（ＡＬＳ）治療剤

RADICAVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of RADICAVA

Introduction to RADICAVA

RADICAVA, also known as edaravone, is a groundbreaking medication approved for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. First approved in Japan in 2015 and later in the United States in 2017, RADICAVA has marked a significant turning point in ALS treatment[1][3].

Mechanism of Action and Clinical Impact

RADICAVA acts as an antioxidant, reducing oxidative stress that contributes to neuronal damage in ALS patients. Clinical trials have demonstrated its efficacy in slowing the decline in physical function, offering hope to those diagnosed with this debilitating condition. The drug is administered via intravenous infusion, typically over a 10- to 14-day cycle, followed by a 14-day treatment-free period[3].

Market Approval and Launch

The FDA approval of RADICAVA in May 2017 was a landmark event, marking the first new ALS therapy approved in the US in 22 years. This approval was expedited due to the critical need for effective ALS treatments and the support of ALS patient groups and caregivers. The drug was launched in the US in August 2017 and quickly gained traction, with over 3,000 patients treated by the end of August 2018[1].

Initial Market Success

The initial launch of RADICAVA was highly successful, generating significant revenue. In 2017, it earned USD 107 million, and this figure increased to approximately USD 233 million in 2018. This strong start was driven by the excitement from advocacy groups and the heavy press coverage surrounding its approval[1][4].

Global Expansion

Following its success in the US, RADICAVA received marketing authorizations in several other countries, including Canada, Switzerland, China, Indonesia, and Thailand. This global expansion has contributed to its growing market presence[1].

Financial Performance

Despite the initial success, RADICAVA's sales have experienced a decline in recent years. Factors contributing to this decline include the National Health Insurance (NHI) drug price revision in Japan and the difficulties patients face in administering the intravenous formulation. In 2019, the revenue dropped to approximately USD 200 million, and in 2020, it further decreased to USD 189 million[1].

Introduction of Oral Formulation

In an effort to address the administration challenges and boost sales, Mitsubishi Tanabe Pharma America introduced an oral formulation of RADICAVA, known as RADICAVA ORS, in June 2022. This oral alternative has been well-received, with over 5,300 patients treated in the US within the first year of its launch. The oral formulation has provided patients with greater flexibility in administration, contributing to increased patient adherence and prescription rates[1].

Current Market Trends and Projections

The ALS treatment market is expected to expand significantly, driven by the increasing prevalence of the disease and growing awareness of available therapies. As of recent estimates, the ALS treatment market is projected to surpass several billion dollars by the next decade. RADICAVA's unique mechanism of action and its position as one of the few approved therapies enhance its market potential[3].

In North America, RADICAVA ORS continues to perform strongly, contributing to volume growth and increased core operating income for Mitsubishi Tanabe Pharma. The company's financial reports indicate that the health care segment, particularly driven by RADICAVA sales, has seen significant growth, with revenue up 8% and core operating income increasing substantially[2].

Challenges and Skepticism

Despite its initial success, there are concerns about RADICAVA's long-term market sustainability. The drug is expensive, with a Wholesale Acquisition Cost (WAC) of $137,400 per year, and offers only modest efficacy improvements compared to other treatments like riluzole. The need for near-daily IV infusions and the lack of data on damage reversal and survival benefits are additional challenges. It has been suggested that for RADICAVA to match the clinical benefit versus cost of other rare disease drugs, its price should be significantly lower, around $55,000 per year[4].

Patient-Centric Care and Market Growth

The evolving ALS treatment landscape emphasizes patient-centric care, prioritizing individual patient needs and ensuring tailored treatment plans. Enhanced patient support programs and educational resources are crucial for fostering adherence to treatment regimens and improving overall outcomes. Initiatives aimed at educating physicians and patients about the importance of early intervention have been pivotal in driving market growth for RADICAVA[3].

Key Takeaways

• Initial Success and Global Expansion: RADICAVA was approved in the US in 2017 and quickly gained traction, with significant revenue in its first years.
• Decline and Rebound: Sales declined due to pricing revisions and administration challenges but are expected to rebound with the introduction of the oral formulation.
• Market Projections: The ALS treatment market is expected to grow significantly, with RADICAVA positioned as a key player.
• Challenges: High cost, modest efficacy improvements, and administration challenges are factors that could impact long-term market sustainability.
• Patient-Centric Care: Emphasis on patient-centric care and educational initiatives is crucial for market growth.

FAQs

Q: What is RADICAVA, and how does it work? A: RADICAVA (edaravone) is an FDA-approved medication that acts as an antioxidant, reducing oxidative stress and slowing the progression of ALS symptoms.

Q: When was RADICAVA approved in the US? A: RADICAVA was approved by the FDA in May 2017.

Q: What are the challenges associated with RADICAVA's administration? A: The intravenous formulation requires near-daily infusions over a 10- to 14-day cycle, which can be inconvenient for patients. The oral formulation, RADICAVA ORS, was introduced to address these challenges.

Q: How has the market performance of RADICAVA been since its launch? A: Initially, RADICAVA generated significant revenue, but sales declined in subsequent years due to pricing revisions and administration challenges. The introduction of the oral formulation is expected to boost sales.

Q: What are the future market projections for RADICAVA? A: The ALS treatment market, including RADICAVA, is expected to grow significantly, surpassing several billion dollars by the next decade.

Sources

1. DelveInsight: "How Does Radicava Work for Amyotrophic Lateral Sclerosis?"
2. Mitsubishi Gas Chemical: "Presentation"
3. Market Research Intellect: "Radicava Market Size And Projection"
4. Equinox Group: "Radicava: Not Innovative Enough to Sustain Strong Start"
5. Mitsubishi Tanabe Pharma: "Financial Results for the Year Ended March 31, 2019"