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Last Updated: May 19, 2022

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 one NDA.

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

Drug patent expirations by year for RADICAVA
Drug Prices for RADICAVA

See drug prices for RADICAVA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for RADICAVA
Generic Entry Date for RADICAVA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
NDA:
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

SponsorPhase
Mitsubishi Tanabe Pharma CorporationPhase 1
ALS CanadaPhase 2
University of CalgaryPhase 2

See all RADICAVA clinical trials

US Patents and Regulatory Information for RADICAVA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RADICAVA is See Plans and Pricing.

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

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-002 Nov 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-001 May 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-002 Nov 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-002 Nov 15, 2018 See Plans and Pricing See Plans and Pricing
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-001 May 5, 2017 See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
Germany 60022560 See Plans and Pricing
Japan WO2002034264 筋萎縮性側索硬化症(ALS)治療剤 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0234264 See Plans and Pricing
European Patent Office 1405637 MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS)) See Plans and Pricing
Austria 303808 See Plans and Pricing
Spain 2248144 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.