Otulfi Purple Book BLA 761379
- BLA number
- 761379
- Proprietary names
- Otulfi
- Proper names
- ustekinumab-aauz
- Applicant
- Fresenius Kabi USA, LLC
- Center
- CDER
- First observed release
- 2024-10-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; 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 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2024-09-27 | |
| 002 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2024-09-27 | |
| 003 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2024-09-27 | |
| 004 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2025-03-21 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2025-05-01 | U | 001 | Otulfi | 351(k) Interchangeable | Rx | Fresenius Kabi USA, LLC |
| 2025-05-01 | U | 002 | Otulfi | 351(k) Interchangeable | Rx | Fresenius Kabi USA, LLC |
| 2025-05-01 | U | 003 | Otulfi | 351(k) Interchangeable | Rx | Fresenius Kabi USA, LLC |
| 2025-05-01 | N | 004 | Otulfi | 351(k) Interchangeable | Rx | Fresenius Kabi USA, LLC |
| 2024-10-01 | N | 001 | Otulfi | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
| 2024-10-01 | N | 002 | Otulfi | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
| 2024-10-01 | N | 003 | Otulfi | 351(k) Biosimilar | Rx | Fresenius Kabi USA, LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-05-01 | 001 | Otulfi | 351(k) Interchangeable | Rx | Licensed | 2024-09-27 |
| 2025-05-01 | 002 | Otulfi | 351(k) Interchangeable | Rx | Licensed | 2024-09-27 |
| 2025-05-01 | 003 | Otulfi | 351(k) Interchangeable | Rx | Licensed | 2024-09-27 |
| 2025-05-01 | 004 | Otulfi | 351(k) Interchangeable | Rx | Licensed | 2025-03-21 |
| 2024-10-01 | 001 | Otulfi | 351(k) Biosimilar | Rx | Licensed | 2024-09-27 |
| 2024-10-01 | 002 | Otulfi | 351(k) Biosimilar | Rx | Licensed | 2024-09-27 |
| 2024-10-01 | 003 | Otulfi | 351(k) Biosimilar | Rx | Licensed | 2024-09-27 |