Argatroban
As of the edition of 20 October 2026, Argatroban is a small molecule: 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
- Small molecule
- Brand name
- Arganova
- First approved
- 30 June 2000 (US)
- Approvals on record
- 14 in 4 regions
- Holder of the most recent approval
- Accord Healthcare; 10 holders in all
- Registered trials
- 27, 5 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Blood and lymph; Infections; Pregnancy and women's health
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.
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 Argatroban.
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 | 3 | 3 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 7 | 6 | 0 | 1 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 12 | 7 | 1 | 4 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eagle Pharmaceuticals | Later holder | 2011 to now |
| Hikma Pharm | Later holder | 2012 to now |
| Teva | Later holder | 2014 to now |
| Fresenius Kabi | Later holder | 2015 to now |
| Aurobindo Pharma | Later holder | 2018 to now |
| Accord Healthcare | Later holder | 2021 to now |
| Eugia Pharma Specialities | Acquired holder | 2021 to now |
| Cipla | Acquired holder | 2022 to now |
| Sandoz | Acquired holder | 2023 to now |
| Plano Pharmaceuticals | Acquired holder | 2025 to now |
| Mitsubishi Tanabe Pharma | Applicant |