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
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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 |
Hannover Medical School | Phase 3 |
King's College Hospital 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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-002 | Jan 8, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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: ⤷ Subscribe
Brazil
Patent: 0809205
Patent: COMPOSIÇÃO FARMACÊUTICA.
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 80039
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1652139
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Patent: 4324015
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Croatia
Patent: 0171384
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 19377
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 40867
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 40867
Patent: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 40867
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 35990
Estimated Expiration: ⤷ Subscribe
Patent: 800007
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 0790
Patent: תכשיר רוקחות בצורה של טבליה מצופה (Pharmaceutical composition in the form of a coated tablet)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 2008129846
Patent: 医薬組成物
Estimated Expiration: ⤷ Subscribe
Patent: 63875
Estimated Expiration: ⤷ Subscribe
Patent: 10090168
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 140867
Estimated Expiration: ⤷ Subscribe
Patent: 2018005
Estimated Expiration: ⤷ Subscribe
Patent: 40867
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 9356
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 1987
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Subscribe
Patent: 09010474
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 9725
Patent: Tablet composition having improved dissolution property
Estimated Expiration: ⤷ Subscribe
Patent: 7109
Patent: Tablet composition having favorable dissolution property useful as an anticoagulant
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 093008
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 012500410
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 40867
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 40867
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 70637
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
Patent: 09139917
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 9497
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 40867
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 0906182
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Patent: 1005906
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1424843
Estimated Expiration: ⤷ Subscribe
Patent: 090122950
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 44803
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 09064
Estimated Expiration: ⤷ Subscribe
Patent: 0845972
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
South Korea | 100908966 | ⤷ Subscribe | |
Canada | 2456841 | ⤷ Subscribe | |
South Korea | 20040029322 | ⤷ Subscribe | |
Israel | 159438 | (CYCLOALKYL)ETHANEDIAMIDE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM | ⤷ Subscribe |
Hong Kong | 1092461 | ⤷ Subscribe | |
>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 | ⤷ Subscribe | 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 |
2140867 | C20180004 00246 | Estonia | ⤷ Subscribe | PRODUCT NAME: EDOKSABAAN;REG NO/DATE: EU/1/15/993 23.06.2015 |
1405852 | C01405852/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015 |
1405852 | CR 2015 00052 | Denmark | ⤷ Subscribe | 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 | 51/2015 | Austria | ⤷ Subscribe | 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 |
SAVAYSA Market Analysis and Financial Projection Experimental
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