Hemlibra Purple Book BLA 761083
- BLA number
- 761083
- Proprietary names
- Hemlibra
- Proper names
- emicizumab-kxwh
- 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
- 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 | Hemlibra | emicizumab-kxwh | 351(a) | 30MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2017-11-16 | |
| 002 | Hemlibra | emicizumab-kxwh | 351(a) | 60MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2017-11-16 | |
| 003 | Hemlibra | emicizumab-kxwh | 351(a) | 105MG/0.7ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2017-11-16 | |
| 004 | Hemlibra | emicizumab-kxwh | 351(a) | 150MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2017-11-16 | |
| 005 | Hemlibra | emicizumab-kxwh | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2023-03-16 | |
| 006 | Hemlibra | emicizumab-kxwh | 351(a) | 12MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | 2024-01-31 | |
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 |
|---|
| 2024-03-01 | N | 005 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2024-03-01 | N | 006 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 001 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 002 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 003 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-08-01 | U | 004 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 001 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 002 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 003 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
| 2020-05-01 | R | 004 | Hemlibra | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-03-01 | 005 | Hemlibra | 351(a) | Rx | Licensed | 2023-03-16 |
| 2024-03-01 | 006 | Hemlibra | 351(a) | Rx | Licensed | 2024-01-31 |
| 2020-05-01 | 001 | Hemlibra | 351(a) | Rx | Licensed | 2017-11-16 |
| 2020-05-01 | 002 | Hemlibra | 351(a) | Rx | Licensed | 2017-11-16 |
| 2020-05-01 | 003 | Hemlibra | 351(a) | Rx | Licensed | 2017-11-16 |
| 2020-05-01 | 004 | Hemlibra | 351(a) | Rx | Licensed | 2017-11-16 |