Darbepoetin alfa
As of the edition of 20 October 2026, Darbepoetin alfa is a protein: marketed, first approved in 2001 (EU); acts on EPOR; US protection ended in 2013.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Protein
- Brand name
- Aranesp
- First approved
- 8 June 2001 (EU)
- Approvals on record
- 78 in 5 regions
- Holder of the most recent approval
- Sanwa Kagaku Kenkyusho; 7 holders in all
- Withdrawn from market
- 5 December 2008 (in some regions)
- Registered trials
- 120, 13 stopped early
- Disease areas
- Blood and lymph; Cancer; Urinary and reproductive; Pregnancy and women's health; Heart and blood vessels; Immune system
US protection
US protection ended in 2013.
US protection ended in 2013, 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 Amgen. 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.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Darbepoetin alfa.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EPOR | Erythropoietin receptor | P19235 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 9 | 3 | 2 |
| Phase 1 | 5 | 4 | 0 | 1 |
| Phase 2 | 40 | 32 | 2 | 4 |
| Phase 3 | 44 | 36 | 1 | 6 |
| Phase 4 | 16 | 15 | 1 | 0 |
| All trials | 120 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 1999 to now |
| Kyowa Kirin | Later holder and Lead sponsor of trials | 2006 to now |
| JCR Pharmaceuticals | Applicant | 2019 to now |
| Sanwa Kagaku Kenkyusho | Later holder | 2019 to now |