Stelara Purple Book BLA 125261
- BLA number
- 125261
- Proprietary names
- Stelara
- Proper names
- ustekinumab
- Applicant
- Janssen Biotech, Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- 6 patents listed; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Stelara | ustekinumab | 351(a) | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2009-09-25 | YES |
| 002 | Stelara | ustekinumab | 351(a) | 90MG/ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | 2009-09-25 | YES |
| 003 | Stelara | ustekinumab | 351(a) | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2009-12-30 | YES |
| 004 | Stelara | ustekinumab | 351(a) | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2009-12-30 | YES |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 10,961,307 | 2039-09-24 | 2025-06-11 |
| 9,217,168 | 2033-03-14 | 2025-06-11 |
| 9,663,810 | 2033-03-14 | 2025-06-11 |
| 8,852,889 | 2032-07-06 | 2025-06-11 |
| 9,475,858 | 2032-07-06 | 2025-06-11 |
| 6,902,734 | 2023-09-25 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-03-01 | U | 001 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2023-03-01 | U | 002 | Stelara | 351(a) | Disc | Janssen Biotech, Inc. |
| 2023-03-01 | U | 003 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2023-03-01 | U | 004 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2021-04-01 | U | 002 | Stelara | 351(a) | Disc | Janssen Biotech, Inc. |
| 2020-05-01 | R | 001 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 002 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 003 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
| 2020-05-01 | R | 004 | Stelara | 351(a) | Rx | Janssen Biotech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2021-04-01 | 002 | Stelara | 351(a) | Disc | Licensed | 2009-09-25 |
| 2020-05-01 | 001 | Stelara | 351(a) | Rx | Licensed | 2009-09-25 |
| 2020-05-01 | 002 | Stelara | 351(a) | Rx | Licensed | 2009-09-25 |
| 2020-05-01 | 003 | Stelara | 351(a) | Rx | Licensed | 2009-12-30 |
| 2020-05-01 | 004 | Stelara | 351(a) | Rx | Licensed | 2009-12-30 |