Ultomiris Purple Book BLA 761108
- BLA number
- 761108
- Proprietary names
- Ultomiris
- Proper names
- ravulizumab-cwvz
- Applicant
- Alexion Pharmaceuticals, 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 | Ultomiris | ravulizumab-cwvz | 351(a) | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2018-12-21 | |
| 002 | Ultomiris | ravulizumab-cwvz | 351(a) | 300MG/3ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2020-10-09 | |
| 003 | Ultomiris | ravulizumab-cwvz | 351(a) | 1,100MG/11ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2020-10-09 | |
| 004 | Ultomiris | ravulizumab-cwvz | 351(a) | 245MG/3.5ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | 2022-06-22 | |
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 |
|---|
| 2022-07-01 | N | 004 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2022-01-01 | U | 003 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2021-07-01 | U | 001 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2021-07-01 | U | 002 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2021-07-01 | U | 003 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-12-01 | U | 001 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-12-01 | U | 002 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-12-01 | U | 003 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-10-01 | N | 002 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-10-01 | N | 003 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-05-01 | R | 001 | Ultomiris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-07-01 | 004 | Ultomiris | 351(a) | Rx | Licensed | 2022-06-22 |
| 2020-10-01 | 002 | Ultomiris | 351(a) | Rx | Licensed | 2020-10-09 |
| 2020-10-01 | 003 | Ultomiris | 351(a) | Rx | Licensed | 2020-10-09 |
| 2020-05-01 | 001 | Ultomiris | 351(a) | Rx | Licensed | 2018-12-21 |