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Last Updated: April 25, 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
Formulation / Manufacturing:	see details
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
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 Class	Factor 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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	92835		⤷ Try a Trial
Denmark	1405852		⤷ Try a Trial
China	100545160		⤷ Try a Trial
Lithuania	C2140867		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for edoxaban tosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2140867	292 50001-2018	Slovakia	⤷ Try a Trial	PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
1405852	CR 2015 00052	Denmark	⤷ Try a Trial	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
1405852	300760	Netherlands	⤷ Try a 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
1405852	1590052-5	Sweden	⤷ Try a Trial	PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE.; REG. NO/DATE: EU/1/15/993/001-028 20150623
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.