Purple Book product · Reference 351(a)
Stelara
ustekinumab
At a glance
Sep 25, 2009
Approved
Reference 351(a)
License type
Rx
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Sep 25, 2009
16 yr 11 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 familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2024OtulfiInterchangeable
ustekinumab-aauz · Fresenius Kabi USA, LLC
- 2024OtulfiInterchangeable
ustekinumab-aauz · Fresenius Kabi USA, LLC
- 2024OtulfiInterchangeable
ustekinumab-aauz · Fresenius Kabi USA, LLC
- 2025OtulfiInterchangeable
ustekinumab-aauz · Fresenius Kabi USA, LLC
- 2024SelarsdiInterchangeable
ustekinumab-aekn · Alvotech USA Inc.
- 2024SelarsdiInterchangeable
ustekinumab-aekn · Alvotech USA Inc.
- 2024SelarsdiInterchangeable
ustekinumab-aekn · Alvotech USA Inc.
- 2025SelarsdiInterchangeable
ustekinumab-aekn · Alvotech USA Inc.
- 2023WezlanaInterchangeable
ustekinumab-auub · Amgen Inc.
Patent list (12)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago | FDA |
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo | FDA |
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
