What is Stelara in the FDA Purple Book?

Stelara, BLA 125261, 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 125261?

Stelara, BLA 125261, lists Janssen Biotech, 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 Stelara?

Stelara, BLA 125261, 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 Stelara's reference-product relationship?

Stelara, BLA 125261, 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 Stelara interchangeable?

Stelara, BLA 125261, 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 Stelara licensed by FDA?

Stelara, BLA 125261, has a listed FDA approval date of Sep 25, 2009. 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 Stelara's FDA label?

Stelara, BLA 125261, 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 Stelara?

Stelara, BLA 125261, has 12 published Purple Book patent rows, with the latest listed expiration on Sep 24, 2039. 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 Stelara?

Stelara, BLA 125261, 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 · 351(a) biologic

Stelara

ustekinumab

Stelara, BLA 125261, 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 125261 4 presentationsRxLicensed Janssen Biotech, Inc.

Approved

Sep 25, 2009

License type

351(a)

Marketing

Listed patents

Stelara (ustekinumab) is Janssen Biotech, Inc.'s FDA-licensed 351(a) biologic under BLA 125261, approved in 2009. The FDA Purple Book lists 12 published patents for it, the last expiring 2039. 5 distinct approved follow-on biologics explicitly reference Stelara (Wezlana, Selarsdi, Otulfi, Yesintek, and Starjemza), 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

125261

Regulatory role

351(a) reference biologic

Applicant

Janssen Biotech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Sep 25, 2009

Follow-on biologics

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

5 distinct licensed follow-on biologics in the loaded Purple Book data name Stelara 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.
Sep 25, 2009
17 yr 3 mo ago
Today

Strengths & presentations

4 FDA presentation rows · BLA 125261

Strength

45MG/0.5ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1864

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	45MG/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx
002	90MG/ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Disc
003	45MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	90MG/ML	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 Stelara; 5 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
Stelaraustekinumab	351(a) reference biologic	125261	Sep 25, 2009	45MG/0.5ML · Subcutaneous	Rx
Wezlanaustekinumab-auub	351(k) interchangeable biosimilar	761331	Oct 31, 2023	130MG/26ML (5MG/ML) · Intravenous	Rx
Selarsdiustekinumab-aekn	351(k) interchangeable biosimilar	761343	Apr 16, 2024	45MG/0.5ML · Subcutaneous	Rx
Otulfiustekinumab-aauz	351(k) interchangeable biosimilar	761379	Sep 27, 2024	45MG/0.5ML · Subcutaneous	Rx
Yesintekustekinumab-kfce	351(k) interchangeable biosimilar	761406	Nov 29, 2024	45MG/0.5ML · Subcutaneous	Rx
Starjemzaustekinumab-hmny	351(k) interchangeable biosimilar	761419	May 22, 2025	45MG/0.5ML · Subcutaneous	Rx

This brand is also licensed under 1 other BLA:

BLA 761044130MG/26ML (5MG/ML)

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
6,902,734	Sep 25, 2023	3 yr ago	FDA
6,902,734	Sep 25, 2023	3 yr ago	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 7 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 7 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 7 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 7 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 2 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 2 mo	FDA

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 Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Janssen Biotech, 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

Stelara 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

Stelara: 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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