RADICAVA Drug Patent Profile

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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 three patents protecting this drug.

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

DrugPatentWatch^® Generic Entry Outlook for Radicava

Radicava was eligible for patent challenges on May 5, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RADICAVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	3
Patent Applications:	2,575
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RADICAVA
What excipients (inactive ingredients) are in RADICAVA?	RADICAVA excipients list
DailyMed Link:	RADICAVA at DailyMed

Drug patent expirations by year for RADICAVA

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

Generic Entry Date for RADICAVA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) NDA: 209176 Dosage: SOLUTION;INTRAVENOUS

^*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

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

Sponsor	Phase
Mitsubishi Tanabe Pharma Corporation	Phase 1
Brain Canada	Phase 2
ALS Canada	Phase 2

See all RADICAVA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RADICAVA

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

US Patents and Regulatory Information for RADICAVA

RADICAVA is protected by zero US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RADICAVA is ⤷ Try a Trial.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting RADICAVA

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Exclusivity Expiration: ⤷ Try a Trial

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mitsubishi Tanabe	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for RADICAVA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017	⤷ Try a Trial	⤷ Try a Trial
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for RADICAVA

See the table below for patents covering RADICAVA around the world.

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Country	Patent Number	Title	Estimated Expiration
Germany	60022560		⤷ Try a Trial
Spain	2248144		⤷ Try a Trial
Japan	WO2002034264	筋萎縮性側索硬化症（ＡＬＳ）治療剤	⤷ Try a Trial
Austria	303808		⤷ Try a Trial
European Patent Office	1405637	MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS))	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration