Coagulation factor x human
As of the edition of 20 October 2026, Coagulation factor x human is a drug: marketed, first approved in 2007 (CA); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Unknown
- Brand name
- Coagadex
- First approved
- 1 May 2007 (CA)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Kedrion; 3 holders in all
- Registered trials
- 5, 2 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Cancer; Immune system; Nutrition and metabolism
US protection
US protection ends in 2030.
The orphan exclusivity ends in 2030 (it covers one use only). The application that gives this date is held by Bio Products Laboratory Limited.
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.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 3 | 4 | 2 | 0 | 2 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Octapharma Pharmazeutika Produktionsges.m.b.H | Applicant | 2007 to now |
| Kedrion | Applicant and Lead sponsor of trials | 2016 to now |