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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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 | 2025-09-25 |
| 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 | 2025-04-14 |
| epoprostenol | ANDA | 2025-04-23 |
| esika hydracolor 2 in 1 spf 25 esika hydracolor 2 in 1 spf 25 | OTC monograph final | 2015-12-07 |
| flector | New Drug Application | 2024-11-28 |
| flolan | New Drug Application | 2016-06-22 |
| licart | New Drug Application | 2024-11-28 |
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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
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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
1014 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 | 23 | 143 | 190 | 85 | 84 | 511 |
| Chronic renal insufficiency | D051436 | — | N18 | 10 | 43 | 81 | 28 | 39 | 199 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 7 | 36 | 44 | 23 | 42 | 149 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 10 | 29 | 30 | 18 | 18 | 100 |
| Neoplasms | D009369 | — | C80 | 6 | 29 | 27 | 7 | 12 | 79 |
| Renal insufficiency | D051437 | — | N19 | 7 | 19 | 22 | 11 | 7 | 63 |
| Myelodysplastic syndromes | D009190 | — | D46 | 4 | 29 | 15 | 2 | 9 | 54 |
| Preleukemia | D011289 | — | — | 2 | 18 | 5 | 2 | 7 | 32 |
| Syndrome | D013577 | — | — | 3 | 18 | 4 | 2 | 8 | 32 |
| Iron-deficiency anemia | D018798 | — | D50 | 2 | 5 | 4 | 5 | 10 | 23 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 21 | 3 | 2 | — | 6 | 30 |
| Leukemia | D007938 | — | C95 | — | 8 | 9 | — | 1 | 17 |
| Multiple myeloma | D009101 | — | C90.0 | — | 4 | 9 | — | 4 | 17 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 4 | 10 | 1 | — | — | 12 |
| Blood transfusion | D001803 | — | — | — | 4 | 5 | — | 6 | 12 |
| Plasma cell neoplasms | D054219 | — | — | — | 3 | 6 | — | 2 | 11 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 5 | 6 | — | — | 11 |
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | 6 | 5 | 3 | — | — | 10 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 6 | 4 | — | 1 | 9 |
| Brain diseases | D001927 | — | G93.40 | 4 | 6 | 3 | — | — | 9 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytopenia | D000095542 | — | — | — | 2 | — | — | 9 | 11 |
| Cardiac surgical procedures | D006348 | — | — | 1 | 2 | — | — | 6 | 8 |
| Ischemic stroke | D000083242 | — | — | 4 | 4 | — | — | — | 6 |
| Depression | D003863 | — | F33.9 | — | 2 | — | — | 2 | 4 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | 1 | 4 |
| Coronary artery disease | D003324 | — | I25.1 | — | 3 | — | — | — | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 1 | — | — | 1 | 3 |
| Reperfusion injury | D015427 | — | — | — | 1 | — | — | 2 | 3 |
| Sclerosis | D012598 | — | — | 2 | 1 | — | — | 1 | 3 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | — | — | 2 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | 3 | 4 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 2 | 3 |
| Cerebral infarction | D002544 | — | I63 | 2 | — | — | — | — | 2 |
| Reticulocyte count | D017701 | — | — | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Autoimmune hepatitis | D019693 | — | K75.4 | 1 | — | — | — | — | 1 |
| Hypogonadism | D007006 | — | E23.0 | 1 | — | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | — | 1 | — | — | — | — | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancytopenia | D010198 | — | D61.81 | — | — | — | — | 8 | 8 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | — | 3 | 3 |
| Iron metabolism disorders | D019189 | — | E83.1 | — | — | — | — | 2 | 2 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 2 | 2 |
| Hemolysis | D006461 | — | — | — | — | — | — | 2 | 2 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 2 | 2 |
| Surgical blood loss | D016063 | — | — | — | — | — | — | 2 | 2 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 2 | 2 |
| Toxemia | D014115 | — | — | — | — | — | — | 2 | 2 |
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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) |
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Retacrit – Pfizer
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Mircera – Roche
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Procrit – Johnson & Johnson
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Epogen – Amgen
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Estimated US medical usage
Epoetin alfa
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Epoetin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 93,438 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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210,388 adverse events reported
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