Factor ix complex
As of the edition of 20 October 2026, Factor ix complex is a drug: marketed, first approved in 1970 (US); acts on F10, F2 and F7 and 3 more; US protection ended in 1982.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1970
- Kind
- Unknown
- Brand name
- Proplex-T; Bebulin
- First approved
- 21 August 1970 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Grifols Biologicals; 2 holders in all
- Registered trials
- 1, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ended in 1982.
US protection ended in 1982, 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 Takeda. 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 product1 listing counts 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 Factor ix complex.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant | 1970 to now |
| Grifols Biologicals | Later holder | 1981 to now |