Spevigo Purple Book BLA 761244
- BLA number
- 761244
- Proprietary names
- Spevigo
- Proper names
- spesolimab-sbzo
- Applicant
- LEO Pharma A/S
- Center
- CDER
- First observed release
- 2022-09-01
- 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 | Spevigo | spesolimab-sbzo | 351(a) | 450MG/7.5ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2022-09-01 | |
| 002 | Spevigo | spesolimab-sbzo | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2024-03-18 | |
| 003 | Spevigo | spesolimab-sbzo | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-05-28 | |
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 | Spevigo | 351(a) | Rx | LEO Pharma A/S |
| 2026-04-01 | U | 002 | Spevigo | 351(a) | Rx | LEO Pharma A/S |
| 2026-04-01 | U | 003 | Spevigo | 351(a) | Rx | LEO Pharma A/S |
| 2025-06-01 | N | 003 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2024-08-01 | U | 001 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2024-08-01 | U | 002 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2024-03-01 | N | 002 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2023-03-01 | U | 001 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2022-09-01 | N | 001 | Spevigo | 351(a) | Rx | Boehringer Ingelheim Pharmaceuticals, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-06-01 | 003 | Spevigo | 351(a) | Rx | Licensed | 2025-05-28 |
| 2024-03-01 | 002 | Spevigo | 351(a) | Rx | Licensed | 2024-03-18 |
| 2022-09-01 | 001 | Spevigo | 351(a) | Rx | Licensed | 2022-09-01 |