EDOXABAN TOSYLATE - Generic Drug Details

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
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

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

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				Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No				Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes				Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No			Y

International Patents for EDOXABAN TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2314303	ПРОИЗВОДНЫЕ ДИАМИНА (DIAMINE DERIVATIVES)
Netherlands	300760
South Africa	200309866	DIAMINE DERIVATIVES
Spain	2389027
Croatia	P20171384

Supplementary Protection Certificates for EDOXABAN TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1405852	CA 2015 00052	Denmark		PRODUCT NAME: EDOXABAN, HERUNDER EDOXABAN TOSILATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
2140867	PA2018005,C2140867	Lithuania		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
1405852	51/2015	Austria		PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619
1405852	132016000024022	Italy		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	122015000077	Germany		PRODUCT NAME: EDOXABAN, DESSEN SALZ, DESSEN SOLVAT, ODER DESSEN N-OXID, INSBESONDERE EDOXABANTOSILAT; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619