Coagulation factor ix recombinant human
As of the edition of 20 October 2026, Coagulation factor ix recombinant human is a protein: marketed, first approved in 1997 (US); US protection ended in 2009.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Protein
- Brand name
- Benefix
- First approved
- 11 February 1997 (US)
- Approvals on record
- 19 in 4 regions
- Holder of the most recent approval
- Baxter Healthcare; 5 holders in all
- Registered trials
- 21, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ended in 2009.
US protection ended in 2009, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
Takeda holds a later exclusivity on its own new formulation or combination product, which ended in 2021; it does not protect the original drug.
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 6 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 9 | 9 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1997 to now |
| Takeda | Applicant, Later holder and Lead sponsor of trials | 2010 to now |
| Baxter Healthcare | Later holder | 2014 to now |