Human coagulation factor viii
As of the edition of 20 October 2026, Human coagulation factor viii is a drug: marketed, first approved in 1974 (US); US protection ended in 1986.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2006
- Kind
- Unknown
- Brand name
- Koate
- First approved
- 24 January 1974 (US)
- Approvals on record
- 43 in 2 regions
- Holder of the most recent approval
- Bayer; 6 holders in all
- Registered trials
- 20, 2 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ended in 1986.
US protection ended in 1986, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
Grifols Biologicals holds a later exclusivity on its own new formulation or combination product, which ended in 2014; 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 product1 listing counts towards this date. The exact date and each listing are in the product.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 10 | 9 | 0 | 1 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grifols Therapeutics | Applicant and Lead sponsor of trials | 1974 to now |
| Takeda | Acquired holder, Later holder and Lead sponsor of trials | 2001 to now |
| CSL Behring | Later holder and Lead sponsor of trials | 2003 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Applicant | 2006 to now |
| Bayer | Later holder | 2016 to now |