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Last Updated: January 28, 2021

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RADICAVA Drug 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. There is one patent protecting this drug.

This drug has seven patent family members in six countries.

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

US ANDA Litigation and Generic Entry Outlook for Radicava

Radicava will be eligible for patent challenges on May 5, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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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Drug patent expirations by year for RADICAVA
Drug Prices for RADICAVA

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Generic Entry Opportunity Date for RADICAVA
Generic Entry Date for RADICAVA*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
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
Brain CanadaPhase 2

See all RADICAVA clinical trials

US Patents and Regulatory Information for RADICAVA

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   Start Trial   Start Trial   Start Trial
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-002 Nov 15, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-001 May 5, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-001 May 5, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mitsubishi Tanabe RADICAVA edaravone SOLUTION;INTRAVENOUS 209176-002 Nov 15, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
McKesson
Boehringer Ingelheim
Johnson and Johnson
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.