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Last Updated: April 13, 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
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
University of BordeauxPhase 3
Azienda Ospedaliera di PerugiaPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting SAVAYSA

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷  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
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  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 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0809205
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 80039
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1652139
Estimated Expiration: ⤷  Try a Trial

Patent: 4324015
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 20955
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0171384
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19377
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 35990
Estimated Expiration: ⤷  Try a Trial

Patent: 800007
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0790
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2008129846
Estimated Expiration: ⤷  Try a Trial

Patent: 63875
Estimated Expiration: ⤷  Try a Trial

Patent: 10090168
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 140867
Estimated Expiration: ⤷  Try a Trial

Patent: 2018005
Estimated Expiration: ⤷  Try a Trial

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9356
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1987
Estimated Expiration: ⤷  Try a Trial

Patent: 09010474
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9725
Estimated Expiration: ⤷  Try a Trial

Patent: 7109
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 093008
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 012500410
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 70637
Estimated Expiration: ⤷  Try a Trial

Patent: 09139917
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 9497
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 40867
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0906182
Estimated Expiration: ⤷  Try a Trial

Patent: 1005906
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1424843
Estimated Expiration: ⤷  Try a Trial

Patent: 090122950
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 44803
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 09064
Estimated Expiration: ⤷  Try a Trial

Patent: 0845972
Estimated Expiration: ⤷  Try a Trial

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 200845972 Pharmaceutical composition ⤷  Try a Trial
Australia 2008241982 Pharmaceutical composition ⤷  Try a Trial
Norway 20035634 ⤷  Try a Trial
China 1894238 ⤷  Try a Trial
Singapore 179497 PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
Russian Federation 2470637 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAVAYSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 SPC/GB15/054 United Kingdom ⤷  Try a Trial PRODUCT NAME: EDOXABAN OR A SALT, SOLVATE OR N-OXIDE THEREOF; REGISTERED: UK EU/1/15/993/001-028 20150623
1405852 122015000077 Germany ⤷  Try a Trial PRODUCT NAME: EDOXABAN, DESSEN SALZ, DESSEN SOLVAT, ODER DESSEN N-OXID, INSBESONDERE EDOXABANTOSILAT; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
1405852 132016000024022 Italy ⤷  Try a Trial 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 C01405852/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
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
2140867 PA2018005,C2140867 Lithuania ⤷  Try a Trial 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.