ustekinumab (Stelara)
ustekinumab is an FDA-licensed reference biologic from Janssen Biotech, Inc., with 8 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
1
Biosimilars
7
Interchangeables
12
Listed patents
2009
Reference approved
Reference product
Stelara ustekinumab
Janssen Biotech, Inc.
- Approved
- Sep 25, 2009
- Marketing
- Rx
- Center
- CDER
- Patents
- 12 listed
Molecular structure
Experimental 3D structure for ustekinumab from the RCSB Protein Data Bank (PDB 3HMW).
Interactive biological assembly from PDB entry 3HMW. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ustekinumab, in chronological order.
Reference approval
Approval date of the reference ustekinumab product.
16 yr 11 mo ago
Patent 6,902,734 expires
Published Purple Book patent expiration.
2 yr 9 mo ago
Patent 6,902,734 expires
Published Purple Book patent expiration.
2 yr 9 mo ago
Patent 8,852,889 expires
Published Purple Book patent expiration.
in 6 yr 2 mo
Patent 8,852,889 expires
Published Purple Book patent expiration.
in 6 yr 2 mo
Patent 9,475,858 expires
Published Purple Book patent expiration.
in 6 yr 2 mo
Patent 9,475,858 expires
Published Purple Book patent expiration.
in 6 yr 2 mo
Patent 9,217,168 expires
Published Purple Book patent expiration.
in 6 yr 11 mo
Patent 9,217,168 expires
Published Purple Book patent expiration.
in 6 yr 11 mo
Patent 9,663,810 expires
Published Purple Book patent expiration.
in 6 yr 11 mo
Patent 9,663,810 expires
Published Purple Book patent expiration.
in 6 yr 11 mo
Patent 10,961,307 expires
Published Purple Book patent expiration.
in 13 yr 6 mo
Patent 10,961,307 expires
Published Purple Book patent expiration.
in 13 yr 6 mo
Biosimilars & interchangeables for ustekinumab
8 FDA-licensed follow-on biologics referencing ustekinumab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Wezlana | ustekinumab-auub | Amgen Inc. | Interchangeable | 761331 | Oct 31, 2023 |
| Selarsdi | ustekinumab-aekn | Alvotech USA Inc. | Interchangeable | 761343 | Apr 16, 2024 |
| Pyzchiva | ustekinumab-ttwe | Samsung Bioepis Co., Ltd. | Interchangeable | 761425 | Jun 28, 2024 |
| Imuldosa | ustekinumab-srlf | Accord BioPharma Inc. | Biosimilar 351(k) | 761364 | Oct 10, 2024 |
| Yesintek | ustekinumab-kfce | Biocon Biologics Inc. | Interchangeable | 761406 | Nov 29, 2024 |
| Steqeyma | ustekinumab-stba | CELLTRION, Inc. | Interchangeable | 761338 | Dec 17, 2024 |
| Otulfi | ustekinumab-aauz | Fresenius Kabi USA, LLC | Interchangeable | 761379 | Mar 21, 2025 |
| Starjemza | ustekinumab-hmny | Bio-Thera Solutions, Ltd. | Interchangeable | 761419 | May 22, 2025 |
Published patents
Patents the BLA holder has published in the FDA Purple Book Patent List for ustekinumab.
| Patent | Expires | In |
|---|---|---|
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago |
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo |
Frequently asked questions
What biosimilars are approved for ustekinumab (Stelara)?
The FDA Purple Book lists 8 approved follow-on biologics referencing ustekinumab: Wezlana, Selarsdi, Pyzchiva, Imuldosa, Yesintek, Steqeyma, Otulfi, and Starjemza. Of these, 7 are interchangeable biosimilars and 1 is a 351(k) biosimilar.
Is there an interchangeable biosimilar for ustekinumab?
Yes. Wezlana, Selarsdi, Pyzchiva, Yesintek, Steqeyma, Otulfi, and Starjemza are approved as interchangeable biosimilars for ustekinumab, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes ustekinumab biosimilars?
Companies with FDA-approved follow-on biologics referencing ustekinumab include Amgen Inc., Alvotech USA Inc., Samsung Bioepis Co., Ltd., Accord BioPharma Inc., Biocon Biologics Inc., CELLTRION, Inc., Fresenius Kabi USA, LLC, and Bio-Thera Solutions, Ltd..
How many patents are listed for ustekinumab (Stelara) in the Purple Book?
12 patents are published in the FDA Purple Book Patent List for ustekinumab.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.