What is Epogen/Procrit in the FDA Purple Book?

Epogen/Procrit, BLA 103234, is listed as a 351(a) reference biologic with 6 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 103234?

Epogen/Procrit, BLA 103234, lists Amgen Inc. 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 Epogen/Procrit?

Epogen/Procrit, BLA 103234, has 6 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 Epogen/Procrit's reference-product relationship?

Epogen/Procrit, BLA 103234, is supported as a reference biologic by exact-BLA evidence and has 1 name-linked 351(k) follow-on product in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Epogen/Procrit interchangeable?

Epogen/Procrit, BLA 103234, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Epogen/Procrit licensed by FDA?

Epogen/Procrit, BLA 103234, does not have an approval or first-licensure date in the loaded Purple Book row. The page keeps that field explicitly unavailable instead of estimating it from another product or source.

Does this page summarize Epogen/Procrit's FDA label?

Epogen/Procrit, BLA 103234, 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 Epogen/Procrit?

Epogen/Procrit, BLA 103234, 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 Epogen/Procrit?

Epogen/Procrit, BLA 103234, has 1 populated Purple Book exclusivity field, with the latest listed date on Dec 31, 1997. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Epogen/Procrit

epoetin alfa

Epogen/Procrit, BLA 103234, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 6 exact FDA presentation rows, and 1 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 103234 6 presentationsRxLicensed Amgen Inc.

Approved

Not listed

License type

351(a)

Marketing

Listed patents

Epogen/Procrit (epoetin alfa) is Amgen Inc.'s FDA-licensed 351(a) biologic under BLA 103234. 1 distinct approved follow-on biologic explicitly reference Epogen/Procrit (Retacrit), making its reference-product role visible in the loaded family data.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

103234

Regulatory role

351(a) reference biologic

Applicant

Amgen Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Not listed

Follow-on biologics

Epogen/Procrit is a 351(a) reference biologic supported by exact-BLA evidence.

1 distinct licensed follow-on biologic in the loaded Purple Book data name Epogen/Procrit as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 31, 1997
29 yr 2 mo ago
Today

Strengths & presentations

6 FDA presentation rows · BLA 103234

Strength

10,000UNITS/ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1080

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	10,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
002	20,000UNITS/2ML (10,000UNITS/ML)	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Licensed	Rx
003	20,000UNITS/ML	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Licensed	Rx
004	2,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
005	3,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
007	4,000UNITS/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx

Other brands under BLA 103234

The rows above are this brand's presentations. FDA also lists the brand below on this BLA, each with its own presentation rows. Strength and reference product come from each brand's own rows; a shared BLA does not establish shared presentations, approved uses, or substitutability.

Procrit
epoetin alfa · Strength: 40,000UNITS/ML

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

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

1 distinct 351(k) follow-on biologic are linked through FDA-stated reference names to Epogen/Procrit; 0 are designated interchangeable and 1 has a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
2018

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Epogen/Procritepoetin alfa	351(a) reference biologic	103234	Not listed	20,000UNITS/2ML (10,000UNITS/ML) · Intravenous, Subcutaneous	Rx
Retacritepoetin alfa-epbx	351(k) biosimilar	125545	May 15, 2018	2,000UNITS/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

6 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

Amgen Inc. 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

Epogen/Procrit is a 351(a) reference biologic supported by exact-BLA evidence. 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
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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

Epogen/Procrit: 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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