Purple Book product · Interchangeable
Otulfi
ustekinumab-aauz
Mar 21, 2025
Approved
Interchangeable
License type
Rx
Marketing
12
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Mar 21, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Strength
45MG/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2146
Product number
004
Submission type
Supplement
Supplement number
2
Change type
Not listed
Reference product family
View full familyBiosimilar of ustekinumab (Stelara)
Patent list (12)
| 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
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
When do Otulfi's patents expire?
The FDA Purple Book lists 12 published patents for Otulfi, 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.
Is Otulfi a biosimilar?
Yes. Otulfi is a Interchangeable referencing ustekinumab, licensed under a 351(k) BLA.
Is Otulfi interchangeable?
Yes. Otulfi carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
What is Otulfi's BLA number?
Otulfi is licensed under BLA 761379, held by Fresenius Kabi USA, LLC.
When was Otulfi approved by the FDA?
Otulfi was approved by the FDA on Mar 21, 2025.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
