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Drug ReportsEpoetin
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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Drug
Target
Variants
Financial
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
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)
Epoetin alfa
Tradename
Proper name
Company
Number
Date
Products
Epogen/Procritepoetin alfaAmgenN-103234 RX
5 products
Procritepoetin alfaAmgenN-103234 RX
1 products
Epogen/Procritepoetin alfaAmgenN-103234 RX1989-06-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
diclofenac epolamineNDA authorized generic2025-06-25
diluent flolanNew Drug Application2023-10-26
epochOTC monograph not final2022-01-12
epoch ava puhi moni anti-dandruffC2002632024-12-31
epogenBiologic Licensing Application2025-04-14
epoprostenolANDA2025-04-23
esika hydracolor 2 in 1 spf 25 esika hydracolor 2 in 1 spf 25OTC monograph final2015-12-07
flectorNew Drug Application2024-11-28
flolanNew Drug Application2016-06-22
licartNew Drug Application2024-11-28
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Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
epoetin alfa, Epogen/Procrit, Amgen, Inc.
1997-12-31Orphan excl.
epoetin alfa, Procrit, Amgen, Inc.
1997-12-31Orphan 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
882 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9—745251794
Chronic renal insufficiencyD051436—N18—31061534
Kidney diseasesD007674EFO_0003086N08—3951633
Myelodysplastic syndromesD009190—D46—4—1—5
PreleukemiaD011289———4—1—5
SyndromeD013577———4—1—5
Renal insufficiencyD051437—N19—11215
Hepatitis cD006526—B19.2—111—3
Chronic hepatitis cD019698EFO_0004220B18.2—111—3
Kidney transplantationD016030—————2—2
Show 3 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
IschemiaD007511EFO_0000556——11——2
HepatitisD006505—K75.9—11——2
Chronic hepatitisD006521—K73.9—11——2
Hepatitis aD006506EFO_0007305B15—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———1———1
Coronary artery diseaseD003324—I25.1—1———1
Myocardial ischemiaD017202EFO_1001375I20-I25—1———1
HemorrhageD006470MP_0001914R58—1———1
Subarachnoid hemorrhageD013345EFO_0000713I60—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
NeoplasmsD009369—C80————22
Body weightD001835EFO_0004338—————11
Birth weightD001724EFO_0004344—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEpoetin alfa
INNepoetin alfa
Description
Erythropoietin precursor (Epoetin)
Classification
Protein
Drug classerythropoietins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201565
ChEBI ID—
PubChem CID—
DrugBankDB00016
UNII ID64FS3BFH5W (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
EPOR
EPOR
Organism
Homo sapiens
Gene name
EPOR
Gene synonyms
NCBI Gene ID
Protein name
erythropoietin receptor
Protein synonyms
Uniprot ID
Mouse ortholog
Epor (13857)
erythropoietin receptor (Q63852)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Procrit – Johnson & Johnson
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Epogen – Amgen
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Mircera – Roche
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Retacrit – Pfizer
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Tabular view
Estimated US medical usage
Epoetin alfa
+
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 91,629 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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60,879 adverse events reported
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