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Last Updated: December 14, 2019

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 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
Formulation / Manufacturing:see details
Generic Entry Opportunity 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)
Paragraph IV (Patent) Challenges for 206316
Tradename Dosage Ingredient NDA Submissiondate
SAVAYSA TABLET;ORAL edoxaban tosylate 206316 2019-01-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jan 8, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 9, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING FROM PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLIND EVALUATOR (PROBE) STUDY EVALUATING THE EFFICACY AND SAFETY OF LOW MOLECULAR WEIGHT HEPARIN/EDOXABAN VERSUS DALTEPARIN IN VENOUS THROMBOEMBOLISM ASSOCIATED WITH CANCER
Regulatory Exclusivity Expiration:Jan 8, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jun 12, 2023Product Flag?Substance Flag?YDelist Request?

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