Bivalirudin
As of the edition of 20 October 2026, Bivalirudin is a protein: marketed, first approved in 2000 (US); acts on F2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- Angiomax
- First approved
- 15 December 2000 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Maia Pharmaceuticals; 4 holders in all
- Withdrawn from market
- 21 June 2018 (in some regions)
- Registered trials
- 51, 5 stopped early
- Disease areas
- Heart and blood vessels; Blood and lymph; Infections; Lungs and airways; Cancer; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| F2 | Prothrombin | P00734 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 4 | 4 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 2 | 1 | 0 |
| Phase 3 | 16 | 10 | 0 | 3 |
| Phase 4 | 20 | 8 | 1 | 1 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Acquired holder | 2018 to now |
| Sandoz | Acquired holder | 2019 to now |
| Maia Pharmaceuticals | Later holder | 2019 to now |