What is Retacrit in the FDA Purple Book?

Retacrit, BLA 125545, is listed as a 351(k) biosimilar with 7 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 125545?

Retacrit, BLA 125545, lists Hospira Inc., a Pfizer Company as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Retacrit?

Retacrit, BLA 125545, has 7 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Retacrit's reference-product relationship?

Retacrit, BLA 125545, lists Procrit as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

Is Retacrit interchangeable?

Retacrit, BLA 125545, is a biosimilar without an interchangeability designation in the loaded Purple Book record. Biosimilar status alone does not establish automatic pharmacy substitution, and this page does not infer interchangeability from shared names, strengths, or routes.

When was Retacrit licensed by FDA?

Retacrit, BLA 125545, has a listed FDA approval date of May 15, 2018. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Retacrit's FDA label?

Retacrit, BLA 125545, FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Retacrit?

Retacrit, BLA 125545, has no published patent rows in the loaded Purple Book patent data. That is a bounded source result, not proof that no relevant patent rights exist or a freedom-to-operate conclusion.

What exclusivity information is listed for Retacrit?

Retacrit, BLA 125545, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · Biosimilar 351(k)

Retacrit

epoetin alfa-epbx

Retacrit, BLA 125545, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 7 exact FDA presentation rows, and FDA names Procrit as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) BiosimilarBLA 125545 7 presentationsRxLicensed Hospira Inc., a Pfizer Company

Approved

May 15, 2018

License type

351(k) Biosimilar

Marketing

Listed patents

Retacrit (epoetin alfa-epbx) is a Biosimilar 351(k) referencing epoetin alfa, licensed under a 351(k) BLA in 2018; the Purple Book lists Hospira Inc., a Pfizer Company as the BLA applicant, not necessarily the manufacturer or commercial supplier.

Sourced from the FDA Purple Book · verified Oct 08, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125545

Regulatory role

351(k) biosimilar

Applicant

Hospira Inc., a Pfizer Company

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

May 15, 2018

Reference product

Procrit

Retacrit is an FDA-licensed biosimilar without an interchangeability designation in this record.

Retacrit was licensed through the 351(k) pathway as biosimilar to Procrit.

Substitution boundary

Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
May 15, 2018
8 yr 6 mo ago
Today

Strengths & presentations

7 FDA presentation rows · BLA 125545

Strength

2,000UNITS/ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1974

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	2,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
002	3,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
003	4,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
004	10,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
005	40,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
006	20,000UNITS/2ML (10,000UNITS/ML)	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Licensed	Rx
007	20,000UNITS/ML	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Candidate awaiting exact-BLA match

FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.

Inspect FDA label candidate

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Retacrit names Procrit as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Procrit

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Epogen/Procritepoetin alfa	351(a) name-matched reference candidate	103234	Jun 01, 1989	10,000UNITS/ML · Intravenous, Subcutaneous	Rx
Retacritepoetin alfa-epbx	351(k) biosimilar	125545	May 15, 2018	4,000UNITS/ML · Intravenous, Subcutaneous	Rx

Published patents

BPCIA 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.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

7 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Intravenous, Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Hospira Inc., a Pfizer Company is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Retacrit is an FDA-licensed biosimilar without an interchangeability designation in this record. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Oct 08, 2026

FDA release · September 2026

FDA source FDA source FDA source

advanced-searchAdvanced Search · Oct 08, 2026
monthly-downloadMonthly download · Oct 08, 2026
monthly-downloadMonthly download · Sep 21, 2026
advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v7Oct 08, 2026
v6Oct 08, 2026
v5Sep 21, 2026
v4Aug 11, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Retacrit: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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