Purple Book product · Reference 351(a)
Epogen/Procrit
epoetin alfa
Not listed
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 31, 1997
29 yr ago
Today
Pharmaceutical detail
Strength
20,000UNITS/2ML (10,000UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
1080
Product number
002
Submission type
Supplement
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.
- —ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- 2018RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
5 additional BLA records for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Epogen/Procrit have approved biosimilars?
Yes. 2 approved follow-on biologics reference Epogen/Procrit in the Purple Book: Procrit and Retacrit.
What is Epogen/Procrit's BLA number?
Epogen/Procrit is licensed under BLA 103234, held by Amgen Inc..
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
