Prothrombin complex concentrate
As of the edition of 20 October 2026, Prothrombin complex concentrate is a protein: marketed, first approved in 2013 (US); US protection ended in 2025.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Protein
- Brand name
- Kcentra
- First approved
- 29 April 2013 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- CSL Behring
- Registered trials
- 26, 5 stopped early
- Disease areas
- Blood and lymph; Heart and blood vessels; Inherited and neonatal; Injuries; Nervous system; Digestive system
US protection
US protection ended in 2025.
US protection ended in 2025, 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 CSL Behring. 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 not stated | 8 | 5 | 2 | 1 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 5 | 1 | 0 | 1 |
| Phase 3 | 6 | 4 | 0 | 2 |
| Phase 4 | 6 | 3 | 2 | 0 |
| All trials | 26 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| CSL Behring | Lead sponsor of trials | 2005 to now |
| Takeda | Lead sponsor of trials | 2010 to now |