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Drug ReportsEpoetin alfa
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
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
epogenBiologic Licensing Application2024-04-30
mirceraBiologic Licensing Application2024-06-05
procritBiologic Licensing Application2024-05-09
retacritBiologic Licensing Application2024-06-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anemiaEFO_0004272D000740D64.9
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
808 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436—N18———112
Kidney diseasesD007674EFO_0003086N08———112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9——2—13
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.6————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‚£
Retacrit – Pfizer
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Procrit – Johnson & Johnson
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Tabular view
Estimated US medical usage
Epoetin alfa
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 66,856 documents
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Safety
Black-box Warning
Black-box warning for: Epogen, Mircera, Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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60,310 adverse events reported
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