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Last Updated: November 15, 2024

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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 five patents protecting this drug.

The generic ingredient in RADICAVA is edaravone. Four 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 6th, 2024.

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Summary for radicava
Drug patent expirations by year for radicava
Drug Prices for radicava

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Recent Clinical Trials for radicava

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SponsorPhase
Auzone Biological Technology Pty LtdPhase 1
Mitsubishi Tanabe Pharma CorporationPhase 1
University of CalgaryPhase 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.

FDA Regulatory Exclusivity protecting radicava

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Exclusivity Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mitsubishi Tanabe RADICAVA ORS edaravone SUSPENSION;ORAL 215446-001 May 12, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mitsubishi Tanabe RADICAVA ORS edaravone SUSPENSION;ORAL 215446-001 May 12, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mitsubishi Tanabe RADICAVA ORS edaravone SUSPENSION;ORAL 215446-001 May 12, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.