What is Neupogen in the FDA Purple Book?

Neupogen, BLA 103353, is listed as a 351(a) reference biologic with 4 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 103353?

Neupogen, BLA 103353, 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 Neupogen?

Neupogen, BLA 103353, has 4 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 Neupogen's reference-product relationship?

Neupogen, BLA 103353, is supported as a reference biologic by exact-BLA evidence and has 5 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 Neupogen interchangeable?

Neupogen, BLA 103353, 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 Neupogen licensed by FDA?

Neupogen, BLA 103353, has a listed FDA approval date of Feb 20, 1991. 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 Neupogen's FDA label?

Neupogen, BLA 103353, 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 Neupogen?

Neupogen, BLA 103353, 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 Neupogen?

Neupogen, BLA 103353, has 1 populated Purple Book exclusivity field, with the latest listed date on Mar 30, 2022. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Neupogen

filgrastim

Neupogen, BLA 103353, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 4 exact FDA presentation rows, and 5 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 103353 4 presentationsRxLicensed Amgen Inc.

Approved

Feb 20, 1991

License type

351(a)

Marketing

Listed patents

Neupogen (filgrastim) is Amgen Inc.'s FDA-licensed 351(a) biologic under BLA 103353, approved in 1991. 5 distinct approved follow-on biologics explicitly reference Neupogen (Zarxio, Nivestym, Releuko, Nypozi, and Filkri), 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

103353

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

Feb 20, 1991

Follow-on biologics

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

5 distinct licensed follow-on biologics in the loaded Purple Book data name Neupogen 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.
Feb 20, 1991
36 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 30, 2022
4 yr 7 mo ago
Today

Strengths & presentations

4 FDA presentation rows · BLA 103353

Strength

300MCG/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	300MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
002	480MCG/1.6ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Rx
003	300MCG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	480MCG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx

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

5 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Neupogen; 0 are designated interchangeable and 5 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
Neupogenfilgrastim	351(a) reference biologic	103353	Feb 20, 1991	480MCG/1.6ML · Intravenous, Subcutaneous	Rx
Zarxiofilgrastim-sndz	351(k) biosimilar	125553	Mar 06, 2015	300MCG/0.5ML · Intravenous, Subcutaneous	Rx
Nivestymfilgrastim-aafi	351(k) biosimilar	761080	Jul 20, 2018	300MCG/ML · Intravenous, Subcutaneous	Rx
Releukofilgrastim-ayow	351(k) biosimilar	761082	Feb 25, 2022	300MCG/ML · Intravenous, Subcutaneous	Rx
Nypozifilgrastim-txid	351(k) biosimilar	761126	Jun 28, 2024	300MCG/0.5ML · Intravenous, Subcutaneous	Rx
Filkrifilgrastim-laha	351(k) biosimilar	761027	Jan 15, 2026	300MCG/0.5ML · 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

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

Administration fields

The loaded rows list Intravenous, Subcutaneous and 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

Neupogen 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

Neupogen: 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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