Apixaban
As of the edition of 20 October 2026, Apixaban is a small molecule: marketed, first approved in 2011 (EU); acts on F10; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Eliquis
- First approved
- 18 May 2011 (EU)
- Approvals on record
- 13 in 7 regions
- Holder of the most recent approval
- Glenmark Arzneimittel; 4 holders in all
- Registered trials
- 233, 17 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Cancer; Blood and lymph; Pregnancy and women's health
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Bristol Myers Squibb.
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 product25 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Apixaban.
See the 2 companies 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 | 87 | 56 | 15 | 5 |
| Phase 1 | 36 | 28 | 4 | 1 |
| Phase 2 | 30 | 17 | 4 | 5 |
| Phase 3 | 41 | 25 | 10 | 3 |
| Phase 4 | 39 | 19 | 13 | 3 |
| All trials | 233 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2008 to now |
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 2011 to now |