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.
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 |
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: | ⤷ Try a Trial | Patent Expiration: | Apr 18, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 28, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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