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radicava ors Drug Patent Profile

When do Radicava Ors patents expire, and what generic alternatives are available?

Radicava Ors is a drug marketed by Mitsubishi Tanabe and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in thirteen countries.

The generic ingredient in RADICAVA ORS is edaravone. One supplier is listed for this compound. Additional details are available on the edaravone profile page.

DrugPatentWatch^® Generic Entry Outlook for Radicava Ors

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2039. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There is one tentative approval for the generic drug (edaravone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for radicava ors

International Patents:	18
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for radicava ors
DailyMed Link:	radicava ors at DailyMed

See drug prices for radicava ors

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for radicava ors

NDA:

215446

Dosage:

SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for radicava ors

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mitsubishi Tanabe Pharma Corporation	Phase 1
University of Calgary	Phase 2
Brain Canada	Phase 2

See all radicava ors clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for radicava ors

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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 four US patents and one FDA Regulatory Exclusivity.

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

Patents protecting radicava ors

FDA Regulatory Exclusivity protecting radicava ors

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
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Mitsubishi Tanabe	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

European Patent Office

Israel

Japan

Mexico

Philippines

Singapore

South Korea

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
European Patent Office	3875085	SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
Singapore	11202104365Q	EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION
Philippines	12021550988	EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION
Argentina	116967	SUSPENSIÓN EDARAVONE PARA ADMINISTRACIÓN ORAL
South Korea	20210087490	경구 투여용 에다라본 현탁액
Japan	2023087011	経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)
China	117379369	依达拉奉在制备用于治疗肌萎缩侧索硬化的口服混悬剂中的用途 (Application of edaravone in preparation of oral suspension for treating amyotrophic lateral sclerosis)