Epoetin alfa
As of the edition of 20 October 2026, Epoetin alfa is a protein: marketed, first approved in 1989 (US); acts on EPOR; US protection ended in 2001.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Epogen/Procrit
- First approved
- 1 June 1989 (US)
- Approvals on record
- 20 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 261, 56 stopped early
- Disease areas
- Blood and lymph; Urinary and reproductive; Cancer; Pregnancy and women's health; Immune system; Heart and blood vessels
US protection
US protection ended in 2001.
US protection ended in 2001, 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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
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 Epoetin 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 | 46 | 28 | 3 | 7 |
| Phase 1 | 21 | 11 | 3 | 1 |
| Phase 2 | 79 | 49 | 3 | 22 |
| Phase 3 | 78 | 48 | 5 | 16 |
| Phase 4 | 37 | 22 | 2 | 10 |
| All trials | 261 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 1989 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 1996 to now |