Epogen/procrit, Neorecormon(epoetin alfa)
Abseamed, Binocrit, Epoetin Alfa, Epogen/Procrit, Procrit, Retacrit (epoetin alfa) is a protein pharmaceutical. Epoetin alfa was first approved as Epogen/procrit on . It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, chronic kidney failure, and neoplasms. It is known to target erythropoietin receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Epogen/procrit, Retacrit
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diclofenac epolamine | NDA authorized generic | 2026-08-24 |
| diclox patch 30ct | NDA authorized generic | 2026-05-22 |
| epoch | C200263 | 2026-06-17 |
| epogen | Biologic Licensing Application | 2026-06-23 |
| epoprostenol | ANDA | 2026-01-06 |
| esfolio hyaluronic protection sunscreen | C200263 | 2026-10-02 |
| esika hydracolor 2 in 1 spf 25 | C200263 | 2025-11-06 |
| esika hydracolor 2 in 1 spf 25 esika hydracolor 2 in 1 spf 25 | OTC monograph final | 2015-12-07 |
| flector | New Drug Application | 2025-10-21 |
| licart | New Drug Application | 2026-11-02 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
epoetin alfa, Epogen/Procrit, Amgen, Inc. | |||
| 1997-12-31 | Orphan excl. | ||
epoetin alfa, Procrit, Amgen, Inc. | |||
| 1997-12-31 | Orphan excl. | ||
Patent Expiration
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ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J0881 | Injection, darbepoetin alfa, 1 microgram (non-esrd use) |
| J0882 | Injection, darbepoetin alfa, 1 microgram (for esrd on dialysis) |
| J0885 | Injection, epoetin alfa, (for non-esrd use), 1000 units |
| Q4081 | Injection, epoetin alfa, 100 units (for esrd on dialysis) |
| Q5105 | Injection, epoetin alfa-epbx, biosimilar, (retacrit) (for esrd on dialysis), 100 units |
| Q5106 | Injection, epoetin alfa-epbx, biosimilar, (retacrit) (for non-esrd use), 1000 units |
Clinical
Clinical Trials
1041 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | 3 | 17 | 22 | 7 | 4 | 50 |
| Neoplasms | D009369 | — | C80 | 1 | 10 | 11 | 2 | — | 22 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | 13 | 5 | 2 | 21 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | 11 | 6 | 2 | 20 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 2 | 3 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 3 | — | 3 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | 1 | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
| Erythrocyte transfusion | D017707 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 2 | — | 1 | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 2 | 3 | — | — | 5 |
| Preleukemia | D011289 | — | — | 1 | 2 | 3 | — | — | 5 |
| Syndrome | D013577 | — | — | 1 | 2 | 2 | — | — | 4 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | 3 | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | — | — | 4 |
| Hematologic neoplasms | D019337 | — | — | 1 | 2 | 1 | — | 1 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | 1 | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | — | — | 2 |
Show 29 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 1 | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | 1 | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | 1 | 2 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
| Pancytopenia | D010198 | — | D61.81 | — | — | — | — | 1 | 1 |
| Cytopenia | D000095542 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epoetin alfa |
| INN | epoetin alfa |
| Description | Erythropoietin precursor (Epoetin) |
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201565 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00016 |
| UNII ID | 64FS3BFH5W (ChemIDplus, GSRS) |
Target
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Financial
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Procrit – Johnson & Johnson
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Epogen – Amgen
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Retacrit – Pfizer
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Mircera – Roche
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Tabular view
Estimated US medical usage
Epoetin alfa
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Epoetin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Diclofenac epolamine, Diclox patch 30ct, Epogen, Flector, Licart, Mircera, Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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230,303 adverse events reported
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