Palivizumab
As of the edition of 20 October 2026, Palivizumab is an antibody: marketed, first approved in 1998 (US); US protection ended in 2010.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Antibody
- Brand name
- Synagis
- First approved
- 19 June 1998 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 3 holders in all
- Registered trials
- 8, 0 stopped early
- Disease areas
- Infections; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Lungs and airways
US protection
US protection ended in 2010.
US protection ended in 2010, 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 Swedish Orphan Biovitrum. 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.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Earlier holder | 1998 to now |
| AbbVie | Applicant and Lead sponsor of trials | 2011 to now |
| Swedish Orphan Biovitrum | Acquired holder | 2020 to now |