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Last Updated: September 27, 2020

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Edoxaban tosylate - Generic Drug Details

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What are the generic drug 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-three countries.

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

Summary for edoxaban tosylate
Recent Clinical Trials for edoxaban tosylate

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

SponsorPhase
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
Paragraph IV (Patent) Challenges for EDOXABAN TOSYLATE
Tradename Dosage Ingredient NDA Submissiondate
SAVAYSA TABLET;ORAL edoxaban tosylate 206316 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 206316-002 Jan 8, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for edoxaban tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2140867 292 50001-2018 Slovakia   Start Trial PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
1405852 2015/045 Ireland   Start Trial PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATIC THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
1405852 1590052-5 Sweden   Start Trial PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE.; REG. NO/DATE: EU/1/15/993/001-028 20150623
1405852 92835 Luxembourg   Start Trial 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
1405852 51/2015 Austria   Start Trial PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619
1405852 300760 Netherlands   Start Trial PRODUCT NAME: EDOXABAN, EEN ZOUT DAARVAN, EEN SOLVAAT DAARVAAN OF EEN N-OXIDE DAARVAN, IN HET BIJZONDER EDOXABAN TOSYLAAT; REGISTRATION NO/DATE: EU/1/15/993 20150619
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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