Eptacog alfa (activated)
As of the edition of 20 October 2026, Eptacog alfa (activated) is a protein: marketed, first approved in 1996 (EU); US protection ended in 2021.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Protein
- Brand name
- Novoseven
- First approved
- 23 February 1996 (EU)
- Approvals on record
- 15 in 3 regions
- Holder of the most recent approval
- Laboratoire Francais du Fractionnement et des Biotechnologies; 3 holders in all
- Registered trials
- 78, 8 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Heart and blood vessels; Injuries; Nervous system; Pregnancy and women's health
US protection
US protection ended in 2021.
The orphan exclusivity ended in 2021 (it covers one use only). The application that gives this date is held by Novo Nordisk.
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 | 27 | 25 | 2 | 0 |
| Phase 1 | 12 | 9 | 0 | 3 |
| Phase 2 | 20 | 17 | 0 | 2 |
| Phase 3 | 12 | 7 | 1 | 3 |
| Phase 4 | 7 | 5 | 2 | 0 |
| All trials | 78 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant and Lead sponsor of trials | 1996 to now |
| Laboratoire Francais du Fractionnement et des Biotechnologies | Later holder | 2020 to now |