Antithrombin iii human
As of the edition of 20 October 2026, Antithrombin iii human is a drug: marketed, first approved in 1988 (ES); acts on F10 and F2; US protection ended in 2003.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Unknown
- Brand name
- Thrombate Iii
- First approved
- 1 March 1988 (ES)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Grifols Therapeutics; 5 holders in all
- Registered trials
- 15, 3 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Digestive system; Infections; Lungs and airways; Pregnancy and women's health
US protection
US protection ended in 2003.
US protection ended in 2003, 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 Grifols Therapeutics. 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.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Antithrombin iii human.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 3 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 5 | 3 | 0 | 1 |
| Phase 3 | 4 | 1 | 3 | 0 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Octapharma | Applicant and Lead sponsor of trials | 1988 to now |
| Grifols Therapeutics | Applicant and Lead sponsor of trials | 1991 to now |
| CSL Behring | Later holder | 1994 to now |
| Takeda | Applicant | 1998 to now |