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FDA Purple Book product · 351(a) biologic

Stelara

ustekinumab

Stelara, BLA 761044, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, 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 761044RxLicensed Janssen Biotech, Inc.
Approved
Sep 23, 2016
License type
351(a)
Marketing
Rx
Listed patents
12
Stelara (ustekinumab) is Janssen Biotech, Inc.'s FDA-licensed 351(a) biologic under BLA 761044, approved in 2016. 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

761044

Regulatory role

351(a) reference biologic

Applicant

Janssen Biotech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

1

Exact FDA presentation rows under this BLA.

Approval

Sep 23, 2016

Follow-on biologics

5

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

  1. Approval

    Approval date of this BLA submission.

    Sep 23, 2016

    10 yr 2 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Strength

130MG/26ML (5MG/ML)

Dosage form

Injection

Route

Intravenous

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
ProductStrengthDosage formRoutePresentationLicensureMarketing
001130MG/26ML (5MG/ML)InjectionIntravenousSingle-Dose VialLicensedRx

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
ProductDesignationBLAApprovedPresentationMarketing
Stelaraustekinumab351(a) reference biologic761044Sep 23, 2016130MG/26ML (5MG/ML) · IntravenousRx
Wezlanaustekinumab-auub351(k) interchangeable biosimilar761285Oct 31, 202345MG/0.5ML · SubcutaneousRx
Selarsdiustekinumab-aekn351(k) interchangeable biosimilar761343Apr 16, 202445MG/0.5ML · SubcutaneousRx
Otulfiustekinumab-aauz351(k) interchangeable biosimilar761379Sep 27, 202445MG/0.5ML · SubcutaneousRx
Yesintekustekinumab-kfce351(k) interchangeable biosimilar761406Nov 29, 202445MG/0.5ML · SubcutaneousRx
Starjemzaustekinumab-hmny351(k) interchangeable biosimilar761419May 22, 202545MG/0.5ML · SubcutaneousRx

This brand is also licensed under 1 other BLA:

Published patents

BPCIA patent list
Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
6,902,734Sep 25, 20233 yr agoFDA
6,902,734Sep 25, 20233 yr agoFDA
8,852,889Jul 06, 2032in 5 yr 10 moFDA
8,852,889Jul 06, 2032in 5 yr 10 moFDA
9,475,858Jul 06, 2032in 5 yr 10 moFDA
9,475,858Jul 06, 2032in 5 yr 10 moFDA
9,217,168Mar 14, 2033in 6 yr 7 moFDA
9,217,168Mar 14, 2033in 6 yr 7 moFDA
9,663,810Mar 14, 2033in 6 yr 7 moFDA
9,663,810Mar 14, 2033in 6 yr 7 moFDA
10,961,307Sep 24, 2039in 13 yr 2 moFDA
10,961,307Sep 24, 2039in 13 yr 2 moFDA

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 Intravenous 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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