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Last Updated: November 30, 2022

Edaravone - Generic Drug Details


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What are the generic sources for edaravone and what is the scope of freedom to operate?

Edaravone is the generic ingredient in two branded drugs marketed by Mitsubishi Tanabe and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Edaravone has twelve patent family members in twelve countries.

One supplier is listed for this compound.

Summary for edaravone
International Patents:12
US Patents:2
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 149
Clinical Trials: 55
Patent Applications: 2,101
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in edaravone?edaravone excipients list
DailyMed Link:edaravone at DailyMed
Recent Clinical Trials for edaravone

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

SponsorPhase
First Affiliated Hospital of Guangxi Medical UniversityN/A
Treeway B.V.Phase 2
NeuroSense Therapeutics Ltd.Phase 2

See all edaravone clinical trials

US Patents and Regulatory Information for edaravone

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 See Plans and Pricing See Plans and Pricing Y 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 ORS edaravone SUSPENSION;ORAL 215446-001 May 12, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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
>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 edaravone

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

International Patents for edaravone

Country Patent Number Title Estimated Expiration
Australia 2019369843 Edaravone suspension for oral administration See Plans and Pricing
European Patent Office 3875085 SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) See Plans and Pricing
Brazil 112021008197 suspensão de edaravone para administração oral See Plans and Pricing
Taiwan 202031256 Edaravone suspension for oral administration See Plans and Pricing
Philippines 12021550988 EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Moodys
Mallinckrodt
Johnson and Johnson
AstraZeneca

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.