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Last Updated: January 28, 2023

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-three 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 Generic Entry Opportunity 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 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SAVAYSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SAVAYSA

INFORMATION ADDED TO LABELING FROM PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLIND EVALUATOR (PROBE) STUDY EVALUATING THE EFFICACY AND SAFETY OF LOW MOLECULAR WEIGHT HEPARIN/EDOXABAN VERSUS DALTEPARIN IN VENOUS THROMBOEMBOLISM ASSOCIATED WITH CANCER
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0809205
Estimated Expiration: See Plans and Pricing

Canada

Patent: 80039
Estimated Expiration: See Plans and Pricing

China

Patent: 1652139
Estimated Expiration: See Plans and Pricing

Patent: 4324015
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 20955
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171384
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19377
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40867
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40867
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 35990
Estimated Expiration: See Plans and Pricing

Patent: 800007
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0790
Estimated Expiration: See Plans and Pricing

Patent: 9829
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2008129846
Estimated Expiration: See Plans and Pricing

Patent: 63875
Estimated Expiration: See Plans and Pricing

Patent: 10090168
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 140867
Estimated Expiration: See Plans and Pricing

Patent: 2018005
Estimated Expiration: See Plans and Pricing

Patent: 40867
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9356
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1987
Estimated Expiration: See Plans and Pricing

Patent: 09010474
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9725
Estimated Expiration: See Plans and Pricing

Patent: 7109
Estimated Expiration: See Plans and Pricing

Norway

Patent: 093008
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 012500410
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40867
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40867
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 70637
Estimated Expiration: See Plans and Pricing

Patent: 09139917
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 9497
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40867
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0906182
Estimated Expiration: See Plans and Pricing

Patent: 1005906
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1424843
Estimated Expiration: See Plans and Pricing

Patent: 090122950
Estimated Expiration: See Plans and Pricing

Spain

Patent: 44803
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 09064
Estimated Expiration: See Plans and Pricing

Patent: 0845972
Estimated Expiration: See Plans and Pricing

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
Portugal 2140867 See Plans and Pricing
European Patent Office 1405852 DERIVES DE DIAMINE (DIAMINE DERIVATIVES) See Plans and Pricing
Australia 2002346300 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAVAYSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 CR 2015 00052 Denmark See Plans and Pricing 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 15C0068 France See Plans and Pricing 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
2140867 292 50001-2018 Slovakia See Plans and Pricing PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Mallinckrodt
Express Scripts
Moodys
Dow

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.