Coagulation factor ix human
As of the edition of 20 October 2026, Coagulation factor ix human is a drug: marketed, first approved in 1990 (US); US protection ended in 2002.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1990
- Kind
- Unknown
- Brand name
- Alphanine
- First approved
- 31 December 1990 (US)
- Approvals on record
- 6 in 1 region
- Holder of the most recent approval
- CSL Behring; 2 holders in all
- Registered trials
- 1, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ended in 2002.
US protection ended in 2002, 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 Grifols Biologicals. 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.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 1 |