Purple Book product · Reference 351(a)

Stelara

ustekinumab

351(a)BLA 125261RxLicensed Janssen Biotech, Inc.

View ustekinumab family Label PDF Open on FDA Purple Book

Sep 25, 2009

Approved

Reference 351(a)

License type

Marketing

Listed patents

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

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Sep 25, 2009
17 yr 1 mo ago
Today

Pharmaceutical detail

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

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

3 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list (12)

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	2 yr 10 mo ago	FDA
6,902,734	Sep 25, 2023	2 yr 10 mo ago	FDA
8,852,889	Jul 06, 2032	in 6 yr 1 mo	FDA
8,852,889	Jul 06, 2032	in 6 yr 1 mo	FDA
9,475,858	Jul 06, 2032	in 6 yr 1 mo	FDA
9,475,858	Jul 06, 2032	in 6 yr 1 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 9 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 9 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 9 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 9 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 5 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 5 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Stelara's patents expire?

The FDA Purple Book lists 12 published patents for Stelara, with the last listed patent expiring Sep 24, 2039. Every patent below links to its FDA source record so you can verify the expiration date.

Does Stelara have approved biosimilars?

Yes. 5 approved follow-on biologics reference Stelara in the Purple Book: Wezlana, Selarsdi, Otulfi, Yesintek, and Starjemza.

What is Stelara's BLA number?

Stelara is licensed under BLA 125261, held by Janssen Biotech, Inc..

When was Stelara approved by the FDA?

Stelara was approved by the FDA on Sep 25, 2009.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo