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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
Summary for SAVAYSA
| International Patents: | 101 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,024 |
| 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 |
| Germans Trias i Pujol Hospital | Phase 3 |
| Julius-Maximilians University | 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 | 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
International Patents for SAVAYSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1405852 | ⤷ Sign up for a Free Trial |
| Taiwan | I298066 | ⤷ Sign up for a Free Trial |
| Brazil | 0210541 | ⤷ Sign up for a Free Trial |
| China | 1894238 | ⤷ Sign up for a Free Trial |
| Slovenia | 2140867 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated 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 |
