Nirsevimab
As of the edition of 20 October 2026, Nirsevimab is an antibody: marketed, first approved in 2022 (EU); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Antibody
- Brand name
- Beyfortus
- First approved
- 31 October 2022 (EU)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 5 holders in all
- Registered trials
- 22, 0 stopped early
- Disease areas
- Infections; Lungs and airways
US protection
US protection ends in 2035.
US protection ends in 2035, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Sanofi. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 1 | 4 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 7 | 5 | 2 | 0 |
| Phase 4 | 4 | 1 | 3 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2014 to now |
| Sanofi | Applicant, Acquired holder and Lead sponsor of trials | 2022 to now |