Fibrinogen, human
As of the edition of 20 October 2026, Fibrinogen, human is a drug: marketed, first approved in 1992 (CH); US protection ended in 2021.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Unknown
- Brand name
- Riastap
- First approved
- 24 November 1992 (CH)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- Octapharma Pharmazeutika Produktionsges.m.b.H; 11 holders in all
- Withdrawn from market
- 19 March 2018 (in some regions)
- Registered trials
- 66, 10 stopped early
- Disease areas
- Blood and lymph; Heart and blood vessels; Inherited and neonatal; Injuries; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2021.
US protection ended in 2021, 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 | 15 | 11 | 1 | 2 |
| Phase 2 | 16 | 7 | 0 | 5 |
| Phase 3 | 21 | 17 | 1 | 2 |
| Phase 4 | 14 | 8 | 0 | 1 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| CSL Behring | Applicant and Lead sponsor of trials | 1992 to now |
| Baxter Healthcare | Later holder | 1994 to now |
| Corza Medical | Applicant and Lead sponsor of trials | 2004 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2006 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Later holder | 2017 to now |
| Instituto Grifols | Later holder and Lead sponsor of trials | 2017 to now |