What is Neulasta in the FDA Purple Book?

Neulasta, BLA 125031, is listed as a 351(a) reference biologic with 1 exact FDA presentation row. 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 125031?

Neulasta, BLA 125031, 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 Neulasta?

Neulasta, BLA 125031, has 1 exact FDA presentation row 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 Neulasta's reference-product relationship?

Neulasta, BLA 125031, is supported as a reference biologic by exact-BLA evidence and has 9 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Neulasta interchangeable?

Neulasta, BLA 125031, 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 Neulasta licensed by FDA?

Neulasta, BLA 125031, has a listed FDA approval date of Jan 31, 2002. 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 Neulasta's FDA label?

Neulasta, BLA 125031, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. 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 Neulasta?

Neulasta, BLA 125031, has 1 published Purple Book patent row, with the latest listed expiration on Jun 21, 2030. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Neulasta?

Neulasta, BLA 125031, has 1 populated Purple Book exclusivity field, with the latest listed date on Nov 13, 2022. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Neulasta

pegfilgrastim

Neulasta, BLA 125031, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, and 9 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 125031RxLicensed Amgen Inc.

Approved

Jan 31, 2002

License type

351(a)

Marketing

Listed patents

Neulasta (pegfilgrastim) is Amgen Inc.'s FDA-licensed 351(a) biologic under BLA 125031, approved in 2002. The FDA Purple Book lists 1 published patent for it, the last expiring 2030. 9 distinct approved follow-on biologics explicitly reference Neulasta (Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend, Udenyca Onbody, Armlupeg, and Ennumo), making its reference-product role visible in the loaded family data.

Sourced from the FDA Purple Book · verified Sep 21, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125031

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

Jan 31, 2002

Follow-on biologics

Neulasta is a 351(a) reference biologic supported by exact-BLA evidence.

9 distinct licensed follow-on biologics in the loaded Purple Book data name Neulasta 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

Approval
Approval date of this BLA submission.
Jan 31, 2002
25 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 13, 2022
3 yr 11 mo ago
Today

Pharmaceutical detail

FDA product record

Strength

6MG/0.6ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

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	6MG/0.6ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx

Other brands under BLA 125031

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.

Neulasta Onpro
pegfilgrastim · Strength: 6MG/0.6ML

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

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

9 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Neulasta; 0 are designated interchangeable and 9 have 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.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Neulastapegfilgrastim	351(a) reference biologic	125031	Jan 31, 2002	6MG/0.6ML · Subcutaneous	Rx
Fulphilapegfilgrastim-jmdb	351(k) biosimilar	761075	Jun 04, 2018	6MG/0.6ML · Subcutaneous	Rx
Udenycapegfilgrastim-cbqv	351(k) biosimilar	761039	Nov 02, 2018	6MG/0.6ML · Subcutaneous	Rx
Ziextenzopegfilgrastim-bmez	351(k) biosimilar	761045	Nov 04, 2019	6MG/0.6ML · Subcutaneous	Rx
Nyvepriapegfilgrastim-apgf	351(k) biosimilar	761111	Jun 10, 2020	6MG/0.6ML · Subcutaneous	Rx
Fylnetrapegfilgrastim-pbbk	351(k) biosimilar	761084	May 26, 2022	6MG/0.6ML · Subcutaneous	Rx
Stimufendpegfilgrastim-fpgk	351(k) biosimilar	761173	Sep 01, 2022	6MG/0.6ML · Subcutaneous	Rx
Udenyca Onbodypegfilgrastim-cbqv	351(k) biosimilar	761039	Dec 22, 2023	6MG/0.6ML · Subcutaneous	Rx
Armlupegpegfilgrastim-unne	351(k) biosimilar	761212	Nov 28, 2025	6MG/0.6ML · Subcutaneous	Rx
Ennumopegfilgrastim-pccg	351(k) biosimilar	761147	May 07, 2026	6MG/0.6ML · Subcutaneous	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
9,856,287	Jun 21, 2030	in 3 yr 10 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

1 exact FDA presentation row is consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list 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

Neulasta 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 Sep 21, 2026

FDA release · August 2026

FDA source FDA source

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

v6Sep 21, 2026
v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Neulasta: 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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