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Last Updated: November 2, 2024

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 and one Paragraph IV challenge. Additional details are available on the SAVAYSA profile page.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206316
Generic Entry Date for 206316*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

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 65597-201-07 7 TABLET, FILM COATED in 1 BOTTLE (65597-201-07)
SAVAYSA edoxaban tosylate TABLET;ORAL 206316 NDA Daiichi Sankyo Inc. 65597-201 65597-201-10 10 TABLET, FILM COATED in 1 BLISTER PACK (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:Oct 18, 2026
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Patent:⤷  Sign UpPatent Expiration:Apr 18, 2027Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 28, 2028Product Flag?YSubstance Flag?Delist Request?

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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 verification 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.