Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215446

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NDA 215446 describes RADICAVA ORS, which is a drug marketed by Shionogi and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the RADICAVA ORS profile page.

The generic ingredient in RADICAVA ORS is edaravone. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 215446
Tradename:RADICAVA ORS
Applicant:Shionogi
Ingredient:edaravone
Patents:12
Suppliers and Packaging for NDA: 215446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RADICAVA ORS edaravone SUSPENSION;ORAL 215446 NDA Shionogi Inc. 70510-2321 70510-2321-2 2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE
RADICAVA ORS edaravone SUSPENSION;ORAL 215446 NDA Shionogi Inc. 70510-2322 70510-2322-1 1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength105MG/5ML
Approval Date:May 12, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:May 12, 2029
Regulatory Exclusivity Use:TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Patent:10,987,341Patent Expiration:Nov 1, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:11,241,416Patent Expiration:Nov 1, 2039Product Flag?YSubstance Flag?Delist Request?

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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