Dabigatran etexilate
As of the edition of 20 October 2026, Dabigatran etexilate is a small molecule: marketed, first approved in 2008 (EU); acts on F2; US protection ended in 2025.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Pradaxa
- First approved
- 17 March 2008 (EU)
- Approvals on record
- 13 in 4 regions
- Holder of the most recent approval
- Boehringer Ingelheim; 2 holders in all
- Registered trials
- 131, 12 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Urinary and reproductive; Cancer; Pregnancy and women's health; Lungs and airways
US protection
US protection ended in 2025.
The last listed US drug-substance patent ended in 2025. The application that gives this date is held by Boehringer Ingelheim.
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 product9 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 Dabigatran etexilate.
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 |
|---|---|---|
| F2 | Prothrombin | P00734 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 11 | 0 | 2 |
| Phase 1 | 72 | 65 | 3 | 3 |
| Phase 2 | 13 | 8 | 0 | 5 |
| Phase 3 | 13 | 11 | 0 | 0 |
| Phase 4 | 17 | 7 | 3 | 2 |
| All trials | 131 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 1998 to now |