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 three branded drugs marketed by Dr Reddys, Gland Pharma Ltd, Hikma, Long Grove Pharms, and Mitsubishi Tanabe, and is included in six NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Edaravone has twenty-one patent family members in fourteen countries.

Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EDARAVONE

International Patents:	21
US Patents:	5
Tradenames:	3
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	57
Patent Applications:	5,767
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARAVONE
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

Sponsor	Phase
Simcere Pharmaceutical Co., Ltd	Phase 3
Xiangya Hospital of Central South University	Phase 3
First Affiliated Hospital of Guangxi Medical University	N/A

See all EDARAVONE clinical trials

Generic filers with tentative approvals for EDARAVONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	30MG/100ML(0.3MG/ML)	INJECTABLE;INJECTION

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

Anatomical Therapeutic Chemical (ATC) Classes for EDARAVONE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	215508-001	May 6, 2024	AP	RX	No	No	⤷ 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				⤷ 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	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	EDARAVONE	edaravone	SOLUTION;INTRAVENOUS	216199-001	May 6, 2024	AP	RX	No	No	⤷ 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

Expired US Patents for EDARAVONE

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

International Patents for EDARAVONE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3875085	SUSPENSION D'ÉDARAVONE DESTINÉE À ÊTRE ADMINISTRÉE PAR VOIE ORALE (EDARAVONE SUSPENSION FOR ORAL ADMINISTRATION)	⤷ Sign Up
Japan	WO2020091036	経口投与用エダラボン懸濁剤	⤷ Sign Up
South Korea	20210087490	경구 투여용 에다라본 현탁액	⤷ Sign Up
Brazil	112021008197	suspensão de edaravone para administração oral	⤷ Sign Up
Japan	7274502		⤷ Sign Up
China	117398346	用于口服给药的依达拉奉混悬剂 (Edaravone suspension for oral administration)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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