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-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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for EDOXABAN TOSYLATE

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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	206316-003	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
>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
Taiwan	I409064		⤷ Sign Up
Canada	2680039	COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)	⤷ Sign Up
China	1826333		⤷ Sign Up
China	1894238		⤷ Sign Up
>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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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