Insulin detemir
As of the edition of 20 October 2026, Insulin detemir is a protein: marketed, first approved in 2004 (EU); acts on INSR; US protection ended in 2017.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Protein
- Brand name
- Levemir
- First approved
- 1 June 2004 (EU)
- Approvals on record
- 14 in 4 regions
- Holder of the most recent approval
- Novo Nordisk; 3 holders in all
- Registered trials
- 139, 12 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Digestive system; Heart and blood vessels; Inherited and neonatal
US protection
US protection ended in 2017.
US protection ended in 2017, 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 Novo Nordisk. 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| INSR | Insulin receptor | P06213 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 56 | 53 | 1 | 2 |
| Phase 1 | 14 | 14 | 0 | 0 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 39 | 34 | 0 | 4 |
| Phase 4 | 27 | 21 | 0 | 6 |
| All trials | 139 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant and Lead sponsor of trials | 1999 to now |