Bimzelx Purple Book BLA 761151
- BLA number
- 761151
- Proprietary names
- Bimzelx
- Proper names
- bimekizumab-bkzx
- Applicant
- UCB, Inc.
- Center
- CDER
- First observed release
- 2023-10-01
- 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 | Bimzelx | bimekizumab-bkzx | 351(a) | 160MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2023-10-17 | |
| 002 | Bimzelx | bimekizumab-bkzx | 351(a) | 160MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-10-17 | |
| 003 | Bimzelx | bimekizumab-bkzx | 351(a) | 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2024-10-11 | |
| 004 | Bimzelx | bimekizumab-bkzx | 351(a) | 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2024-10-11 | |
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 |
|---|
| 2024-11-01 | N | 003 | Bimzelx | 351(a) | Rx | UCB, Inc. |
| 2024-11-01 | N | 004 | Bimzelx | 351(a) | Rx | UCB, Inc. |
| 2023-10-01 | N | 001 | Bimzelx | 351(a) | Rx | UCB, Inc. |
| 2023-10-01 | N | 002 | Bimzelx | 351(a) | Rx | UCB, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-11-01 | 003 | Bimzelx | 351(a) | Rx | Licensed | 2024-10-11 |
| 2024-11-01 | 004 | Bimzelx | 351(a) | Rx | Licensed | 2024-10-11 |
| 2023-10-01 | 001 | Bimzelx | 351(a) | Rx | Licensed | 2023-10-17 |
| 2023-10-01 | 002 | Bimzelx | 351(a) | Rx | Licensed | 2023-10-17 |