Thrombin
As of the edition of 20 October 2026, Thrombin is a drug: marketed, first approved in 1994 (CH); US protection ended in 2019.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Unknown
- Brand name
- Evithrom
- First approved
- 2 June 1994 (CH)
- Approvals on record
- 13 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Withdrawn from market
- 19 March 2018 (in some regions)
- Registered trials
- 23, 1 stopped early
- Disease areas
- Cancer; Digestive system; Nervous system; Bones, joints and muscles; Injuries; Heart and blood vessels
US protection
US protection ended in 2019.
US protection ended in 2019, 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 Johnson & Johnson. 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.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 7 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 8 | 6 | 1 | 0 |
| Phase 4 | 6 | 1 | 1 | 1 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Applicant | 1994 to now |
| Corza Medical | Applicant and Lead sponsor of trials | 2004 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2004 to now |
| Instituto Grifols | Later holder and Lead sponsor of trials | 2013 to now |