Details for New Drug Application (NDA): 206316
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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 Action | Factor 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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Jan 8, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 18, 2026 | ||||||||
Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 18, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 28, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
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