Xolair Purple Book BLA 103976
- BLA number
- 103976
- Proprietary names
- Xolair
- Proper names
- omalizumab
- Applicant
- Genentech, Inc.
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- 8 patents listed; 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 | Xolair | omalizumab | 351(a) | 150MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2003-06-20 | YES |
| 002 | Xolair | omalizumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2018-09-28 | YES |
| 003 | Xolair | omalizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2018-09-28 | YES |
| 004 | Xolair | omalizumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2023-08-17 | YES |
| 005 | Xolair | omalizumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-08-17 | YES |
| 006 | Xolair | omalizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-08-17 | YES |
| 007 | Xolair | omalizumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2023-08-17 | YES |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | Rx | 2026-06-01 |
Published Patent List#
Patent, Expiration, Source updated table| Patent | Expiration | Source updated |
|---|
| 12,030,959 | 2043-07-20 | 2025-06-11 |
| 10,017,732 | 2034-03-14 | 2025-06-11 |
| 10,676,710 | 2034-03-14 | 2025-06-11 |
| 10,829,732 | 2034-03-14 | 2025-06-11 |
| 11,078,294 | 2028-07-08 | 2025-06-11 |
| 11,987,637 | 2028-07-08 | 2025-06-11 |
| 8,574,869 | 2028-07-08 | 2025-06-11 |
| 10,034,940 | 2025-11-04 | 2025-06-11 |
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2024-09-01 | U | 001 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 002 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 003 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 004 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 005 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 006 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-09-01 | U | 007 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-02-01 | N | 004 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-02-01 | N | 005 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-02-01 | N | 006 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2024-02-01 | N | 007 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 001 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 002 | Xolair | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 003 | Xolair | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-02-01 | 004 | Xolair | 351(a) | Rx | Licensed | 2023-08-17 |
| 2024-02-01 | 005 | Xolair | 351(a) | Rx | Licensed | 2023-08-17 |
| 2024-02-01 | 006 | Xolair | 351(a) | Rx | Licensed | 2023-08-17 |
| 2024-02-01 | 007 | Xolair | 351(a) | Rx | Licensed | 2023-08-17 |
| 2020-05-01 | 001 | Xolair | 351(a) | Rx | Licensed | 2003-06-20 |
| 2020-05-01 | 002 | Xolair | 351(a) | Rx | Licensed | 2018-09-28 |
| 2020-05-01 | 003 | Xolair | 351(a) | Rx | Licensed | 2018-09-28 |