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SAVAYSA Drug Profile
» See Plans and Pricing
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.
US ANDA Litigation and 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 122 |
| Clinical Trials: | 9 |
| Patent Applications: | 71 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SAVAYSA |
| DailyMed Link: | SAVAYSA at DailyMed |
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 |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Phase 3 |
| Medical University of Graz | Phase 3 |
| University of Birmingham | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| SAVAYSA | TABLET;ORAL | edoxaban tosylate | 206316 | 2019-01-28 |
US Patents and Regulatory Information for SAVAYSA
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-002 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-002 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101652139 | Start Trial |
| Malaysia | 153231 | Start Trial |
| Norway | 20040557 | Start Trial |
| China | 104324015 | Start Trial |
| Poland | 368402 | Start Trial |
| South Africa | 200400926 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SAVAYSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1405852 | 132016000024022 | Italy | Start Trial | PRODUCT NAME: EDOXABAN, UN SUO SALE, UN SUO SOLVATO O UN SUO N-OSSIDO, IN PARTICOLARE EDOXABAN TOSILATO(LIXIANA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/993/001-028, 20150623 |
| 1405852 | CA 2015 00052 | Denmark | Start Trial | PRODUCT NAME: EDOXABAN, HERUNDER EDOXABAN TOSILATE; REG. NO/DATE: EU/1/15/993/001-028 20150623 |
| 1405852 | 51/2015 | Austria | Start Trial | PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619 |
| 2140867 | 292 50001-2018 | Slovakia | Start Trial | PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623 |
| 1405852 | C01405852/01 | Switzerland | Start Trial | PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015 |
| 1405852 | 2015/045 | Ireland | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
