Efmoroctocog alfa
As of the edition of 20 October 2026, Efmoroctocog alfa is a protein: marketed, first approved in 2014 (US); US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- Eloctate
- First approved
- 6 June 2014 (US)
- Approvals on record
- 12 in 3 regions
- Holder of the most recent approval
- Bioverativ Therapeutics; 3 holders in all
- Registered trials
- 16, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2026.
US protection ended in 2026, 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 Bioverativ 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.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 1 | 1 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Applicant | 2014 to now |
| Swedish Orphan Biovitrum | Applicant and Lead sponsor of trials | 2015 to now |