Epoetin Alfa-Epbx

Treats anemia due to o Chronic Kidney Disease (CKD). Sold as Retacrit. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Epoetin Alfa-Epbx (sold as Retacrit), first approved May 15, 2018, with 1 new use approved and 0 published complete response letters.

First approved: May 15, 2018
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $77.2M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Retacrit (Q5106)	Part B	$39.7M	-7%	25,107
Retacrit	Part D	$37.1M	+37%	18,461
Retacrit (Q5105)	Part B	$481K	+9%	1,471

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

RETACRIT 10,000 UNIT/ML VIAL: $112.68 per MLBrand · +5% in a year
RETACRIT 2,000 UNIT/ML VIAL: $22.52 per MLBrand · +5% in a year
RETACRIT 20,000 UNIT/ML VIAL: $224.79 per MLBrand · +5% in a year
RETACRIT 40,000 UNIT/ML VIAL: $448.01 per MLBrand · new this year

Orphan Designations (FDA)

3 designations, 2 approved for the designated use; see all orphan designations

Treatment of myelodysplastic syndrome.Johnson & Johnson Pharmaceutical Research & Dev., · designated Dec 20, 1993
Treatment of anemia associated with HIV infection or HIV treatment.Amgen, Inc. · designated Jul 1, 1991 · approved Dec 31, 1990
Treatment of anemia associated with end stage renal disease.Amgen, Inc. · designated Apr 10, 1986 · approved Jun 1, 1989

Approvals in the EU (EMA)

Centrally authorised medicines, matched by ingredient; see all EU approvals

Binocrit, biosimilarSandoz GmbH · Aug 28, 2007
Epoetin Alfa Hexal, biosimilarHexal AG · Aug 27, 2007
Abseamed, biosimilarMedice Arzneimittel Pütter GmbH Co. KG · Aug 27, 2007

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial)Myelodysplastic Syndrome · National Cancer Institute (NCI)	Phase 2	Not yet recruiting	Mar 11, 2026
Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular HemorrhageIntraventricular Hemorrhage of Prematurity · Johns Hopkins University	Phase 1	Recruiting	Nov 16, 2022
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm · National Cancer Institute (NCI)	Phase 2	Recruiting	Oct 3, 2022
Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and AnemiaAnemia, Chronic Myelomonocytic Leukemia · National Cancer Institute (NCI)	Phase 3	Active, not recruiting	Feb 13, 2009

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
May 15, 2018	RetacritBLA 125545 · New formulation or manufacturer	Hospira Inc	4	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA