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Last Updated: January 30, 2023

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
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: 33
Clinical Trials: 3
Patent Applications: 1,564
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in edoxaban tosylate?edoxaban tosylate excipients list
DailyMed Link:edoxaban tosylate at DailyMed
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 Action Factor Xa Inhibitors
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 206316-001 Jan 8, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Russian Federation 2009139917 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ See Plans and Pricing
Denmark 1405852 See Plans and Pricing
Colombia 6220955 UNA COMPOSICION FARMACEUTICA QUE CONTIENE (A) N1-(5-CLOROPIRIDIN-2-IL)-N2-((1S,2R,4S)-4-[DIMETILAMINO)CARBONIL]-2-{[(5-METIL-4,5,6,7-TETRAHIDROTIAZOL[5,4-C]PIRIDIN-2-IL) CARBONIL] AMINO} COCLOHEXIL)ETANODIAMIDA See Plans and Pricing
European Patent Office 2343290 See Plans and Pricing
China 100545160 See Plans and Pricing
Hungary E035990 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for edoxaban tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2140867 292 50001-2018 Slovakia See Plans and Pricing PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
1405852 15C0068 France See Plans and Pricing PRODUCT NAME: EDOXABAN,UN SEL,SOLVATE OU N-OXYDE DE CELUI-CI,EN PARTICULIER L'EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993 20150619
1405852 132016000024022 Italy See Plans and Pricing PRODUCT NAME: EDOXABAN, UN SUO SALE, UN SUO SOLVATO O UN SUO N-OSSIDO, IN PARTICOLARE EDOXABAN TOSILATO(LIXIANA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/993/001-028, 20150623
1405852 SPC/GB15/054 United Kingdom See Plans and Pricing PRODUCT NAME: EDOXABAN OR A SALT, SOLVATE OR N-OXIDE THEREOF; REGISTERED: UK EU/1/15/993/001-028 20150623
1405852 CA 2015 00052 Denmark See Plans and Pricing PRODUCT NAME: EDOXABAN, HERUNDER EDOXABAN TOSILATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
1405852 2015/045 Ireland See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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