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Generated: November 14, 2018

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Details for New Drug Application (NDA): 209176

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NDA 209176 describes RADICAVA, which is a drug marketed by Mitsubishi Tanabe and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RADICAVA profile page.

The generic ingredient in RADICAVA is edaravone. One supplier is listed for this compound. Additional details are available on the edaravone profile page.
Summary for 209176
Tradename:RADICAVA
Applicant:Mitsubishi Tanabe
Ingredient:edaravone
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209176
Generic Entry Date for 209176*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Dosage:
SOLUTION;IV (INFUSION)

*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.

Suppliers and Packaging for NDA: 209176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RADICAVA edaravone SOLUTION;INTRAVENOUS 209176 NDA Mitsubishi Tanabe Pharma America, Inc. 70510-2171 70510-2171-2 2 BAG in 1 CARTON (70510-2171-2) > 100 mL in 1 BAG (70510-2171-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength30MG/100ML (0.3MG/ML)
Approval Date:May 5, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:May 5, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 5, 2024
Regulatory Exclusivity Use:TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Patent:➤ Sign UpPatent Expiration:Nov 13, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)

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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 verifification 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.