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Last Updated: November 2, 2024

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SAVAYSA Drug Patent Profile


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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

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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: 378
Drug Prices: Drug price information for SAVAYSA
What excipients (inactive ingredients) are in SAVAYSA?SAVAYSA excipients list
DailyMed Link:SAVAYSA at DailyMed
Drug patent expirations by year for SAVAYSA
Drug Prices for SAVAYSA

See drug prices for SAVAYSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SAVAYSA
Generic Entry Date for SAVAYSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Population Health Research InstitutePhase 3
Azienda Ospedaliera di PerugiaPhase 3
Hull University Teaching Hospitals NHS TrustPhase 3

See all SAVAYSA clinical trials

Pharmacology for SAVAYSA
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SAVAYSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Diamine derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting SAVAYSA

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 206316-003 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 206316-001 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 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

Patent: 08241982
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0809205
Patent: COMPOSIÇÃO FARMACÊUTICA.
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 80039
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1652139
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

Patent: 4324015
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 20955
Patent: UNA COMPOSICION FARMACEUTICA QUE CONTIENE (A) N1-(5-CLOROPIRIDIN-2-IL)-N2-((1S,2R,4S)-4-[DIMETILAMINO)CARBONIL]-2-{[(5-METIL-4,5,6,7-TETRAHIDROTIAZOL[5,4-C]PIRIDIN-2-IL) CARBONIL] AMINO} COCLOHEXIL)ETANODIAMIDA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0171384
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19377
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 40867
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 40867
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 40867
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 35990
Estimated Expiration: ⤷  Sign Up

Patent: 800007
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0790
Patent: תכשיר רוקחות בצורה של טבליה מצופה (Pharmaceutical composition in the form of a coated tablet)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2008129846
Patent: 医薬組成物
Estimated Expiration: ⤷  Sign Up

Patent: 63875
Estimated Expiration: ⤷  Sign Up

Patent: 10090168
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 140867
Estimated Expiration: ⤷  Sign Up

Patent: 2018005
Estimated Expiration: ⤷  Sign Up

Patent: 40867
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 9356
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 1987
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷  Sign Up

Patent: 09010474
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9725
Patent: Tablet composition having improved dissolution property
Estimated Expiration: ⤷  Sign Up

Patent: 7109
Patent: Tablet composition having favorable dissolution property useful as an anticoagulant
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 093008
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 012500410
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 40867
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 40867
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 70637
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 09139917
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 9497
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 40867
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0906182
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Patent: 1005906
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1424843
Estimated Expiration: ⤷  Sign Up

Patent: 090122950
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 44803
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 09064
Estimated Expiration: ⤷  Sign Up

Patent: 0845972
Patent: Pharmaceutical composition
Estimated Expiration: ⤷  Sign Up

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
Taiwan I409064 ⤷  Sign Up
Canada 2680039 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
China 1826333 ⤷  Sign Up
China 1894238 ⤷  Sign Up
Israel 160204 DIAMINE DERIVATIVES, SALTS THEREOF AND SOLVATES AND N-OXIDES THEREOF WHICH EXIBIT POTENT FXa-INHIBITING EFFECT AND ANTICOAGULANT EFFECT ⤷  Sign Up
Japan 4331595 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAVAYSA

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
2140867 292 50001-2018 Slovakia ⤷  Sign Up PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
2140867 PA2018005 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
>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.