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
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: | 417 |
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 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
Sponsor | Phase |
---|---|
Population Health Research Institute | Phase 3 |
Hull University Teaching Hospitals NHS Trust | Phase 3 |
Medical University of Graz | Phase 3 |
Pharmacology for SAVAYSA
Drug Class | Factor 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 ⤷ 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
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 |
---|---|---|---|
Canada | 2456841 | ⤷ Try a Trial | |
Israel | 160204 | DIAMINE DERIVATIVES, SALTS THEREOF AND SOLVATES AND N-OXIDES THEREOF WHICH EXIBIT POTENT FXa-INHIBITING EFFECT AND ANTICOAGULANT EFFECT | ⤷ Try a Trial |
South Korea | 100908966 | ⤷ Try a Trial | |
Poland | 368402 | ⤷ Try a Trial | |
Poland | 220739 | ⤷ Try a Trial | |
Brazil | 0210541 | ⤷ 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 |
---|---|---|---|---|
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 |
1405852 | 2015/045 | Ireland | ⤷ Try a 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 | C01405852/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015 |
1405852 | 612 | Finland | ⤷ Try a Trial | |
1405852 | 1590052-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE.; REG. NO/DATE: EU/1/15/993/001-028 20150623 |
1405852 | 51/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |