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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SAVAYSA?
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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: | 378 |
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 |
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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Patent Expiration: ⤷ Sign Up
Pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting SAVAYSA
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-002 | Jan 8, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0809205
Patent: COMPOSIÇÃO FARMACÊUTICA.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 80039
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1652139
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Patent: 4324015
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 20955
Patent: UNA COMPOSICION FARMACEUTICA QUE CONTIENE (A) N1-(5-CLOROPIRIDIN-2-IL)-N2-((1S,2R,4S)-4-[DIMETILAMINO)CARBONIL]-2-{[(5-METIL-4,5,6,7-TETRAHIDROTIAZOL[5,4-C]PIRIDIN-2-IL) CARBONIL] AMINO} COCLOHEXIL)ETANODIAMIDA
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0171384
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 19377
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 40867
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 40867
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 40867
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 35990
Estimated Expiration: ⤷ Sign Up
Patent: 800007
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0790
Patent: תכשיר רוקחות בצורה של טבליה מצופה (Pharmaceutical composition in the form of a coated tablet)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2008129846
Patent: 医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 63875
Estimated Expiration: ⤷ Sign Up
Patent: 10090168
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 140867
Estimated Expiration: ⤷ Sign Up
Patent: 2018005
Estimated Expiration: ⤷ Sign Up
Patent: 40867
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9356
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1987
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up
Patent: 09010474
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9725
Patent: Tablet composition having improved dissolution property
Estimated Expiration: ⤷ Sign Up
Patent: 7109
Patent: Tablet composition having favorable dissolution property useful as an anticoagulant
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 093008
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 012500410
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 40867
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 40867
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 70637
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Patent: 09139917
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 9497
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 40867
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0906182
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Patent: 1005906
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1424843
Estimated Expiration: ⤷ Sign Up
Patent: 090122950
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 44803
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 09064
Estimated Expiration: ⤷ Sign Up
Patent: 0845972
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
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 | I409064 | ⤷ Sign Up | |
Canada | 2680039 | COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
China | 1826333 | ⤷ Sign Up | |
China | 1894238 | ⤷ Sign Up | |
Israel | 160204 | DIAMINE DERIVATIVES, SALTS THEREOF AND SOLVATES AND N-OXIDES THEREOF WHICH EXIBIT POTENT FXa-INHIBITING EFFECT AND ANTICOAGULANT EFFECT | ⤷ Sign Up |
Japan | 4331595 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAVAYSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1405852 | 51/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619 |
1405852 | SPC/GB15/054 | United Kingdom | ⤷ Sign Up | 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 | PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015 |
2140867 | C20180004 00246 | Estonia | ⤷ Sign Up | PRODUCT NAME: EDOKSABAAN;REG NO/DATE: EU/1/15/993 23.06.2015 |
2140867 | 292 50001-2018 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623 |
2140867 | PA2018005 | Lithuania | ⤷ Sign Up | 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 |