Simoctocog alfa
As of the edition of 20 October 2026, Simoctocog alfa is a protein: marketed, first approved in 2014 (EU); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Protein
- Brand name
- Nuwiq
- First approved
- 22 July 2014 (EU)
- Approvals on record
- 19 in 4 regions
- Holder of the most recent approval
- Octapharma Pharmazeutika Produktionsges.m.b.H; 3 holders in all
- Registered trials
- 12, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ends in 2027.
US protection ends in 2027, 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 Octapharma Pharmazeutika Produktionsges.m.b.H. 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 | 1 | 0 | 1 | 0 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 7 | 6 | 0 | 1 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Octapharma | Applicant and Lead sponsor of trials | 2010 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Applicant | 2014 to now |