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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206316

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NDA 206316 describes SAVAYSA, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SAVAYSA profile page.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the edoxaban tosylate profile page.
Summary for 206316
Tradename:SAVAYSA
Applicant:Daiichi Sankyo Inc
Ingredient:edoxaban tosylate
Patents:2
Pharmacology for NDA: 206316
Mechanism of ActionFactor Xa Inhibitors
Suppliers and Packaging for NDA: 206316
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAVAYSA edoxaban tosylate TABLET;ORAL 206316 NDA Daiichi Sankyo, Inc. 65597-201 N 65597-201-07
SAVAYSA edoxaban tosylate TABLET;ORAL 206316 NDA Daiichi Sankyo, Inc. 65597-201 N 65597-201-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jan 8, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 8, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jun 12, 2023Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Mar 28, 2028Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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