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SAVAYSA Drug Patent Profile

When do Savaysa patents expire, and when can generic versions of Savaysa launch?

Savaysa is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in thirty-four countries.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the edoxaban tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Savaysa

Savaysa was eligible for patent challenges on January 8, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 28, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for SAVAYSA

International Patents:	101
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	11
Patent Applications:	417
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SAVAYSA
What excipients (inactive ingredients) are in SAVAYSA?	SAVAYSA excipients list
DailyMed Link:	SAVAYSA at DailyMed

See drug prices for SAVAYSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SAVAYSA

NDA:

206316

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 SAVAYSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Population Health Research Institute	Phase 3
East Kent Hospitals University NHS Foundation Trust	Phase 3
Johannes Wesling Klinikum Minden	Phase 3

See all SAVAYSA clinical trials

Pharmacology for SAVAYSA

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for SAVAYSA

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 SAVAYSA

SAVAYSA is protected by two US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SAVAYSA

FDA Regulatory Exclusivity protecting SAVAYSA

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	206316-003	Jan 8, 2015		RX	Yes	Yes			Y
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 SAVAYSA

When does loss-of-exclusivity occur for SAVAYSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SAVAYSA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	556066
Australia	2002346300
Norway	20035634
Slovenia	2140867
China	104324015	PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for SAVAYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1405852	15C0068	France		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	CR 2015 00052	Denmark		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	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	92835	Luxembourg		PRODUCT NAME: EDOXABAN, UN DE SES SELS, UN DE SES SOLVATES OU UN N-OXYDE DE CELUI-CI, EN PARTICULIER UN TOSYLATE D EDOXABAN. FIRST REGISTRATION: 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