Baloxavir marboxil
As of the edition of 20 October 2026, Baloxavir marboxil is a small molecule: marketed, first approved in 2018 (JP); US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Xofluza
- First approved
- 23 February 2018 (JP)
- Approvals on record
- 14 in 4 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 18, 1 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Cancer
US protection
US protection ends in 2037.
The last listed US drug-substance patent ends in 2037. The application that gives this date is held by Roche.
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 product24 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 24 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 2 | 1 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 11 | 7 | 4 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 18 |