FDA.reportPublic FDA data

Retacrit Purple Book BLA 125545

BLA number
125545
Proprietary names
Retacrit
Proper names
epoetin alfa-epbx
Applicant
Hospira Inc., a Pfizer Company
Center
CDER
First observed release
2020-02-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Retacritepoetin alfa-epbx351(k) Biosimilar2,000UNITS/MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2018-05-15
002Retacritepoetin alfa-epbx351(k) Biosimilar3,000UNITS/MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2018-05-15
003Retacritepoetin alfa-epbx351(k) Biosimilar4,000UNITS/MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2018-05-15
004Retacritepoetin alfa-epbx351(k) Biosimilar10,000UNITS/MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2018-05-15
005Retacritepoetin alfa-epbx351(k) Biosimilar40,000UNITS/MLInjectionIntravenous, SubcutaneousSingle-Dose VialRxLicensed2018-05-15
006Retacritepoetin alfa-epbx351(k) Biosimilar20,000UNITS/2ML (10,000UNITS/ML)InjectionIntravenous, SubcutaneousMulti-Dose VialRxLicensed2020-06-30
007Retacritepoetin alfa-epbx351(k) Biosimilar20,000UNITS/MLInjectionIntravenous, SubcutaneousMulti-Dose VialRxLicensed2020-06-30

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103234Epogen/Procritepoetin alfa351(a)Rx2026-06-01

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2020-10-01U001Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U002Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U003Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U004Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U005Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U006Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-10-01U007Retacrit351(k) BiosimilarRxHospira Inc., a Pfizer Company
2020-07-01N006Retacrit351(k) BiosimilarRxHospira, Inc.
2020-07-01N007Retacrit351(k) BiosimilarRxHospira, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-07-01006Retacrit351(k) BiosimilarRxLicensed2020-06-30
2020-07-01007Retacrit351(k) BiosimilarRxLicensed2020-06-30
2020-05-01001Retacrit351(k) BiosimilarRxLicensed2018-05-15
2020-05-01002Retacrit351(k) BiosimilarRxLicensed2018-05-15
2020-05-01003Retacrit351(k) BiosimilarRxLicensed2018-05-15
2020-05-01004Retacrit351(k) BiosimilarRxLicensed2018-05-15
2020-05-01005Retacrit351(k) BiosimilarRxLicensed2018-05-15
2020-02-01001Retacrit351(k) BiosimilarMarketedLicensed2018-05-15
2020-02-01002Retacrit351(k) BiosimilarMarketedLicensed2018-05-15
2020-02-01003Retacrit351(k) BiosimilarMarketedLicensed2018-05-15
2020-02-01004Retacrit351(k) BiosimilarMarketedLicensed2018-05-15
2020-02-01005Retacrit351(k) BiosimilarMarketedLicensed2018-05-15