Cosentyx Purple Book BLA 125504
- BLA number
- 125504
- Proprietary names
- Cosentyx
- Proper names
- secukinumab
- Applicant
- Novartis Pharmaceuticals Corporation
- 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 | Cosentyx | secukinumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2015-01-21 | |
| 002 | Cosentyx | secukinumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2015-01-21 | |
| 003 | Cosentyx | secukinumab | 351(a) | 150MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | 2015-01-21 | |
| 004 | Cosentyx | secukinumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2021-05-28 | |
| 005 | Cosentyx | secukinumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-05-11 | |
| 006 | Cosentyx | secukinumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | 2023-05-11 | |
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 |
|---|
| 2026-04-01 | U | 003 | Cosentyx | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-09-01 | U | 005 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2023-08-01 | U | 005 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2023-06-01 | U | 003 | Cosentyx | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-06-01 | U | 005 | Cosentyx | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-06-01 | U | 006 | Cosentyx | 351(a) | Disc | Novartis Pharmaceuticals Corporation |
| 2023-05-01 | N | 005 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2023-05-01 | N | 006 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2021-05-01 | N | 004 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-05-01 | R | 001 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-05-01 | R | 002 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
| 2020-05-01 | R | 003 | Cosentyx | 351(a) | Rx | Novartis Pharmaceuticals Corporation |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-04-01 | 003 | Cosentyx | 351(a) | Disc | Voluntarily Revoked | 2015-01-21 |
| 2023-08-01 | 005 | Cosentyx | 351(a) | Rx | Licensed | 2023-05-11 |
| 2023-06-01 | 003 | Cosentyx | 351(a) | Disc | Licensed | 2015-01-21 |
| 2023-06-01 | 005 | Cosentyx | 351(a) | Disc | Licensed | 2023-05-11 |
| 2023-06-01 | 006 | Cosentyx | 351(a) | Disc | Licensed | 2023-05-11 |
| 2023-05-01 | 005 | Cosentyx | 351(a) | Rx | Licensed | 2023-05-11 |
| 2023-05-01 | 006 | Cosentyx | 351(a) | Rx | Licensed | 2023-05-11 |
| 2021-05-01 | 004 | Cosentyx | 351(a) | Rx | Licensed | 2021-05-28 |
| 2020-05-01 | 001 | Cosentyx | 351(a) | Rx | Licensed | 2015-01-21 |
| 2020-05-01 | 002 | Cosentyx | 351(a) | Rx | Licensed | 2015-01-21 |
| 2020-05-01 | 003 | Cosentyx | 351(a) | Rx | Licensed | 2015-01-21 |