Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209176

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NDA 209176 describes RADICAVA, which is a drug marketed by Shionogi and is included in two NDAs. There are twelve patents protecting this drug. Additional details are available on the RADICAVA profile page.

The generic ingredient in RADICAVA is edaravone. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.

Summary for 209176

Tradename:	RADICAVA
Applicant:	Shionogi
Ingredient:	edaravone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	30MG/100ML (0.3MG/ML)
Approval Date:	May 5, 2017	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/100ML (0.6MG/ML)
Approval Date:	Nov 15, 2018	TE:		RLD:	Yes

Expired US Patents for NDA 209176

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

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