Antithrombin alfa
As of the edition of 20 October 2026, Antithrombin alfa is a protein: marketed, first approved in 2009 (US); acts on F10 and F2; US protection ended in 2021.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Protein
- Brand name
- Atryn
- First approved
- 6 February 2009 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- rEVO Biologics
- Withdrawn from market
- 22 December 2018 (in some regions)
- Registered trials
- 10, 5 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Heart and blood vessels
US protection
US protection ended in 2021.
US protection ended in 2021, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by rEVO Biologics. The date is computed, not published.
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 product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Antithrombin alfa.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 1 | 0 | 0 | 1 |
| Phase 3 | 4 | 3 | 0 | 1 |
| Phase 4 | 2 | 0 | 0 | 2 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| rEVO Biologics | Applicant and Lead sponsor of trials | 2002 to now |