Respiratory syncytial virus pre-fusion glycoprotein f
As of the edition of 20 October 2026, Respiratory syncytial virus pre-fusion glycoprotein f is a vaccine component: marketed, first approved in 2023 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Vaccine component
- Brand name
- Arexvy
- First approved
- 3 May 2023 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 16, 0 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Cancer; Immune system
US protection
US protection ends in 2035.
The reference-product exclusivity ends in 2035. The application that gives this date is held by GSK.
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 | 7 | 1 | 6 | 0 |
| Phase 2 | 2 | 0 | 2 | 0 |
| Phase 3 | 5 | 2 | 3 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 16 |