Edoxaban
As of the edition of 20 October 2026, Edoxaban is a small molecule: marketed, first approved in 2015 (US); acts on F10; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Savaysa
- First approved
- 8 January 2015 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Stemline Therapeutics; 3 holders in all
- Registered trials
- 105, 2 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Blood and lymph; Lungs and airways; Cancer; Pregnancy and women's health
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Daiichi Sankyo.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Edoxaban.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| F10 | Coagulation factor X | P00742 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 36 | 24 | 4 | 0 |
| Phase 1 | 10 | 7 | 1 | 0 |
| Phase 2 | 17 | 14 | 1 | 0 |
| Phase 3 | 29 | 20 | 4 | 1 |
| Phase 4 | 13 | 9 | 2 | 1 |
| All trials | 105 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator, Applicant and Lead sponsor of trials | 2005 to now |
| Stemline Therapeutics | Later holder | 2017 to now |