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Last Updated: January 16, 2022

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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-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

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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
Germans Trias i Pujol HospitalPhase 3
Julius-Maximilians UniversityPhase 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 NDA Submissiondate
SAVAYSA TABLET;ORAL edoxaban tosylate 206316 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 for a Free Trial.

This potential generic entry date is based on patent ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Pharmaceutical composition
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

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: ⤷  Sign up for a Free 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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-003 Jan 8, 2015 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SAVAYSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 2015/045 Ireland ⤷  Sign up for a Free Trial PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATIC THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
1405852 SPC/GB15/054 United Kingdom ⤷  Sign up for a Free Trial 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 for a Free Trial PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
1405852 15C0068 France ⤷  Sign up for a Free Trial 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 C20180004 00246 Estonia ⤷  Sign up for a Free Trial PRODUCT NAME: EDOKSABAAN;REG NO/DATE: EU/1/15/993 23.06.2015
>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.