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Last Updated: April 22, 2024

Edaravone - Generic Drug Details


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What are the generic drug sources for edaravone and what is the scope of patent protection?

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

Edaravone has eighteen patent family members in thirteen countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for edaravone
International Patents:18
US Patents:4
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 157
Clinical Trials: 56
Patent Applications: 5,840
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in edaravone?edaravone excipients list
DailyMed Link:edaravone at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for edaravone
Generic Entry Dates for edaravone*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for edaravone*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL

*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 edaravone

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

SponsorPhase
Xiangya Hospital of Central South UniversityPhase 3
First Affiliated Hospital of Guangxi Medical UniversityN/A
Treeway B.V.Phase 2

See all edaravone clinical trials

Generic filers with tentative approvals for EDARAVONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial60mg/100mLINJECTION;SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EDARAVONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RADICAVA ORS Oral Suspension edaravone 105 mg/5 mL 215446 1 2023-04-20

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 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 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 ORS edaravone SUSPENSION;ORAL 215446-001 May 12, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 Y ⤷  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 edaravone

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 edaravone

Country Patent Number Title Estimated Expiration
China 117398346 用于口服给药的依达拉奉混悬剂 (Edaravone suspension for oral administration) ⤷  Try a Trial
Japan 7274502 ⤷  Try a Trial
Argentina 116967 SUSPENSIÓN EDARAVONE PARA ADMINISTRACIÓN ORAL ⤷  Try a Trial
China 112969459 用于口服给药的依达拉奉混悬剂 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) ⤷  Try a Trial
Japan 2023087011 経口投与用エダラボン懸濁剤 (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION) ⤷  Try a Trial
China 117379370 用于口服给药的依达拉奉混悬剂 (Edaravone suspension for oral administration) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.