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
Summary for SAVAYSA
International Patents: | 101 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 47 |
Clinical Trials: | 11 |
Patent Applications: | 474 |
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 |


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
Sponsor | Phase |
---|---|
Population Health Research Institute | Phase 3 |
Azienda Ospedaliera di Perugia | Phase 3 |
Hull University Teaching Hospitals NHS Trust | Phase 3 |
Pharmacology for SAVAYSA
Drug Class | Factor Xa Inhibitor |
Mechanism of Action | Factor Xa Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SAVAYSA
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 |