Baloxavir marboxil is an FDA-approved oral antiviral for both the treatment and prevention of influenza. An oral one-dose, one-time treatment for influenza, could serve, in addition to its use in seasonal influenza, as a valuable tool in pandemic preparedness in the event of an outbreak with a highly virulent influenza strain. Single oral administration, with no requirement for companion drugs, would support simplified treatment delivery. As a drug in a new class of antiviral treatment for influenza, it could provide an additional layer of protection. WHO has included baloxavir marboxil in its 2024 revised influenza guidelines. A conditional recommendation was made for administering baloxavir marboxil to asymptomatic individuals exposed to zoonotic influenza viruses, such as H5N1, that are associated with high mortality. Baloxavir marboxil has also the potential to reduce influenza transmission due to a rapid effect in decreasing viral shedding.

Primary patents on baloxavir marboxil have been filed or granted in several LMICs to Shionogi and they are expected to expire between 2030-2036. Secondary patents may provide exclusivity in few LMICs until 2039.

acronyms & abbreviations list