Soliris Purple Book BLA 125166
- BLA number
- 125166
- Proprietary names
- Soliris
- Proper names
- eculizumab
- 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 | Soliris | eculizumab | 351(a) | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2007-03-16 | |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761333 | Bkemv | eculizumab-aeeb | 351(k) Interchangeable | Rx | 2026-06-01 |
| 761340 | Epysqli | eculizumab-aagh | 351(k) Interchangeable | Rx | 2026-06-01 |
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 |
|---|
| 2026-04-01 | U | 001 | Soliris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-08-01 | U | 001 | Soliris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2020-05-01 | R | 001 | Soliris | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Soliris | 351(a) | Rx | Licensed | 2007-03-16 |