Edoxaban tosylate - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for edoxaban tosylate and what is the scope of freedom to operate?
Edoxaban tosylate
is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Edoxaban tosylate has one hundred and one patent family members in thirty-four countries.
There are four drug master file entries for edoxaban tosylate. One supplier is listed for this compound.
Summary for edoxaban tosylate
International Patents: | 101 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 3 |
Patent Applications: | 1,213 |
What excipients (inactive ingredients) are in edoxaban tosylate? | edoxaban tosylate excipients list |
DailyMed Link: | edoxaban tosylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for edoxaban tosylate
Generic Entry Date for edoxaban tosylate*:
Constraining patent/regulatory exclusivity:
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 edoxaban tosylate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Daiichi Sankyo, Inc. | Phase 2 |
Daiichi Sankyo Inc. | Phase 2 |
Daiichi Sankyo Inc. | Phase 3 |
Pharmacology for edoxaban tosylate
Drug Class | Factor Xa Inhibitor |
Mechanism of Action | Factor Xa Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for edoxaban tosylate
Paragraph IV (Patent) Challenges for EDOXABAN TOSYLATE
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 edoxaban tosylate
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 | 206316-003 | 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 | |||
>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 edoxaban tosylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 2140867 | ⤷ Sign Up | |
Taiwan | 200845972 | Pharmaceutical composition | ⤷ Sign Up |
Russian Federation | 2470637 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
New Zealand | 597109 | Tablet composition having favorable dissolution property useful as an anticoagulant | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for edoxaban tosylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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,C2140867 | 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 |
1405852 | 132016000024022 | Italy | ⤷ Sign Up | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.