Skyrizi Purple Book BLA 761105
- BLA number
- 761105
- Proprietary names
- Skyrizi
- Proper names
- risankizumab-rzaa
- Applicant
- AbbVie Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- 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 | Skyrizi | risankizumab-rzaa | 351(a) | 75MG/0.83ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2019-04-23 | |
| 002 | Skyrizi | risankizumab-rzaa | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2021-04-26 | |
| 003 | Skyrizi | risankizumab-rzaa | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2021-04-26 | |
| 004 | Skyrizi | risankizumab-rzaa | 351(a) | 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2022-09-23 | |
| 005 | Skyrizi | risankizumab-rzaa | 351(a) | 360MG/2.4ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2022-06-16 | |
| 006 | Skyrizi | risankizumab-rzaa | 351(a) | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2023-03-22 | |
| 007 | Skyrizi | risankizumab-rzaa | 351(a) | 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-09-03 | |
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 |
|---|
| 2025-09-01 | N | 007 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2023-05-01 | U | 006 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2023-04-01 | U | 001 | Skyrizi | 351(a) | Disc | AbbVie Inc. |
| 2023-04-01 | N | 007 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2022-09-01 | N | 004 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2022-09-01 | U | 005 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2022-09-01 | U | 006 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2022-06-01 | N | 004 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2022-06-01 | N | 005 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 002 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2021-06-01 | U | 003 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2021-04-01 | N | 002 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2021-04-01 | N | 003 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
| 2020-05-01 | R | 001 | Skyrizi | 351(a) | Rx | AbbVie Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-09-01 | 007 | Skyrizi | 351(a) | Rx | Licensed | 2025-09-03 |
| 2023-05-01 | 006 | Skyrizi | 351(a) | Rx | Licensed | 2023-03-22 |
| 2023-04-01 | 001 | Skyrizi | 351(a) | Disc | Licensed | 2019-04-23 |
| 2023-04-01 | 007 | Skyrizi | 351(a) | Rx | Licensed | 2023-03-22 |
| 2022-09-01 | 004 | Skyrizi | 351(a) | Rx | Licensed | 2022-09-23 |
| 2022-09-01 | 006 | Skyrizi | 351(a) | Rx | Licensed | 2022-06-16 |
| 2022-06-01 | 004 | Skyrizi | 351(a) | Rx | Licensed | 2022-06-16 |
| 2022-06-01 | 005 | Skyrizi | 351(a) | Rx | Licensed | 2022-06-16 |
| 2021-04-01 | 002 | Skyrizi | 351(a) | Rx | Licensed | 2021-04-26 |
| 2021-04-01 | 003 | Skyrizi | 351(a) | Rx | Licensed | 2021-04-26 |
| 2020-05-01 | 001 | Skyrizi | 351(a) | Rx | Licensed | 2019-04-23 |