Beyfortus Purple Book BLA 761328
- BLA number
- 761328
- Proprietary names
- Beyfortus
- Proper names
- nirsevimab-alip
- Applicant
- Sanofi Vaccines US Inc.
- Center
- CDER
- First observed release
- 2023-07-01
- 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 | Beyfortus | nirsevimab-alip | 351(a) | 50MG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2023-07-17 | |
| 002 | Beyfortus | nirsevimab-alip | 351(a) | 100MG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2023-07-17 | |
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 | Beyfortus | 351(a) | Rx | Sanofi Vaccines US Inc. |
| 2026-04-01 | U | 002 | Beyfortus | 351(a) | Rx | Sanofi Vaccines US Inc. |
| 2026-03-01 | U | 001 | Beyfortus | 351(a) | Rx | Sanofi Pasteur Inc. |
| 2026-03-01 | U | 002 | Beyfortus | 351(a) | Rx | Sanofi Pasteur Inc. |
| 2026-02-01 | U | 001 | Beyfortus | 351(a) | Rx | Sanofi Pasteur Inc. |
| 2026-02-01 | U | 002 | Beyfortus | 351(a) | Rx | Sanofi Pasteur Inc. |
| 2024-03-01 | N | 002 | Beyfortus | 351(a) | Rx | AstraZeneca AB |
| 2023-07-01 | N | 001 | Beyfortus | 351(a) | Rx | AstraZeneca AB |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-03-01 | 002 | Beyfortus | 351(a) | Rx | Licensed | 2023-07-17 |
| 2023-07-01 | 001 | Beyfortus | 351(a) | Rx | Licensed | 2023-07-17 |