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 | 2026-01-05 |
| diluent flolan | New Drug Application | 2023-10-26 |
| epoch | OTC monograph not final | 2022-01-12 |
| epoch ava puhi moni anti-dandruff | C200263 | 2024-12-31 |
| epogen | Biologic Licensing Application | 2025-11-05 |
| epoprostenol | ANDA | 2026-01-06 |
| 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 |
| flolan | New Drug Application | 2016-06-22 |
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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
No data
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
1020 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 | — | 7 | 44 | 25 | 18 | 94 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 3 | 5 | 6 | 15 | 29 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 3 | 4 | 5 | 16 | 28 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 4 | — | 1 | — | 5 |
| Preleukemia | D011289 | — | — | — | 4 | — | 1 | — | 5 |
| Syndrome | D013577 | — | — | — | 4 | — | 1 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | 1 | 2 | 1 | 5 |
| Hepatitis c | D006526 | — | B19.2 | — | 1 | 1 | 1 | — | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 1 | 1 | 1 | — | 3 |
| Kidney transplantation | D016030 | — | — | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | 1 | — | — | 2 |
| Hepatitis | D006505 | — | K75.9 | — | 1 | 1 | — | — | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 1 | 1 | — | — | 2 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 1 | 1 | — | — | 2 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | — | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | 1 | — | — | — | 1 |
| Aneurysm | D000783 | — | I72.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | — | — | — | 2 | 2 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 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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Epogen – Amgen
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Procrit – Johnson & Johnson
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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, Epogen, Flector, Licart, Mircera, Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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213,816 adverse events reported
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