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Generated: December 10, 2018

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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 edoxaban tosylate 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. Additional information is available in the individual branded drug profile pages.

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

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

Pharmacology for edoxaban tosylate
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Synonyms for edoxaban tosylate
32W99UE810
3601AH
4-methylbenzene-1-sulfonic acid--N(1)-(5-chloropyridin-2-yl)-N(2)-{(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide (1/1)
480449-71-6
AK143317
AKOS022186217
C24H30ClN7O4S.C7H8O3S
CHEBI:85975
CHEMBL2105682
CS-1332
D0SL8X
DTXSID10197399
DU 176b
DU-176b
Edoxaban (tosylate)
edoxaban 4-toluenesulfonate
edoxaban monotosylate
edoxaban p-toluenesulfonate
Edoxaban tosilate
Edoxaban tosylate [USAN]
Edoxaban TsOH
Ethanediamide, N-(5-chloro-2-pyridinyl)-N'-((1S,2R,4S)-4-((dimethylamino)carbonyl)-2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-, mono(4-methylbenzenesulfonate)
Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-((1S,2R,4S)-4-((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-, 4-methylbenzenesulfonate (1:1)
HY-10264A
Lixiana
N-(5-Chloropyridin-2-yl)-N'-((1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide, 4- methylbenzenesulfonate
N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide p-toluenesulfonic acid
SCHEMBL330918
UNII-32W99UE810
W-5624
ZLFZITWZOYXXAW-QXXZOGQOSA-N

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 Y ➤ 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 206316-002 Jan 8, 2015 RX Yes No ➤ 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 206316-002 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

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Supplementary Protection Certificates for edoxaban tosylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2018005 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
15/045 Ireland ➤ Sign Up 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
0760 Netherlands ➤ Sign Up 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
C0068 France ➤ Sign Up 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
2015 00052 Denmark ➤ Sign Up PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Julphar
Moodys
Argus Health
McKinsey
Colorcon
Johnson and Johnson
McKesson
AstraZeneca

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