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Last Updated: November 2, 2024

Edoxaban tosylate - Generic Drug Details


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What are the generic sources for edoxaban tosylate and what is the scope of freedom to operate?

Edoxaban tosylate is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Edoxaban tosylate has one hundred and one patent family members in thirty-four countries.

There are four drug master file entries for edoxaban tosylate. One supplier is listed for this compound.

Summary for edoxaban tosylate
International Patents:101
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 3
Patent Applications: 1,213
What excipients (inactive ingredients) are in edoxaban tosylate?edoxaban tosylate excipients list
DailyMed Link:edoxaban tosylate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for edoxaban tosylate
Generic Entry Date for edoxaban tosylate*:
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.

Recent Clinical Trials for edoxaban tosylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daiichi Sankyo Inc.Phase 2
Daiichi Sankyo, Inc.Phase 2
Daiichi Sankyo, Inc.Phase 3

See all edoxaban tosylate clinical trials

Pharmacology for edoxaban tosylate
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for edoxaban tosylate
Paragraph IV (Patent) Challenges for EDOXABAN TOSYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAVAYSA Tablets edoxaban tosylate 15 mg, 30 mg and 60 mg 206316 1 2019-01-28

US Patents and Regulatory Information for edoxaban tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for edoxaban tosylate

Country Patent Number Title Estimated Expiration
Taiwan I409064 ⤷  Sign Up
Canada 2680039 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
China 1826333 ⤷  Sign Up
China 1894238 ⤷  Sign Up
Israel 160204 DIAMINE DERIVATIVES, SALTS THEREOF AND SOLVATES AND N-OXIDES THEREOF WHICH EXIBIT POTENT FXa-INHIBITING EFFECT AND ANTICOAGULANT EFFECT ⤷  Sign Up
Japan 4331595 ⤷  Sign Up
European Patent Office 1415992 DERIVES DE DIAMINE (DIAMINE DERIVATIVES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for edoxaban tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 51/2015 Austria ⤷  Sign Up PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619
1405852 SPC/GB15/054 United Kingdom ⤷  Sign Up PRODUCT NAME: EDOXABAN OR A SALT, SOLVATE OR N-OXIDE THEREOF; REGISTERED: UK EU/1/15/993/001-028 20150623
1405852 C01405852/01 Switzerland ⤷  Sign Up PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
2140867 C20180004 00246 Estonia ⤷  Sign Up PRODUCT NAME: EDOKSABAAN;REG NO/DATE: EU/1/15/993 23.06.2015
2140867 292 50001-2018 Slovakia ⤷  Sign Up PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
2140867 PA2018005 Lithuania ⤷  Sign Up PRODUCT NAME: EDOKSABANAS, JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ARBA BET KURIO IS JU HIDRATAS, YPAC EDOKSABANO P-TOLUENSULFONATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
1405852 92835 Luxembourg ⤷  Sign Up PRODUCT NAME: EDOXABAN, UN DE SES SELS, UN DE SES SOLVATES OU UN N-OXYDE DE CELUI-CI, EN PARTICULIER UN TOSYLATE D EDOXABAN. FIRST REGISTRATION: 20150619
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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