Roche and the Medicines Patent Pool (MPP) have announced they have signed a voluntary licence agreement to expand access to baloxavir marboxil (Xofluza) across 129 low- and middle-income countries (LMICs).
The agreement will allow qualified generic manufacturers to develop, produce and supply baloxavir marboxil independently for the first time.
Currently, the drug is produced exclusively by Roche's subsidiary Genentech, with no FDA-approved generic available and patent protection extending to 2038.
The deal represents a significant step toward diversifying the antiviral supply chain for one of the world's most prevalent infectious diseases.
Baloxavir marboxil is a cap-dependent endonuclease inhibitor approved for the treatment of uncomplicated influenza and post-exposure prophylaxis in patients from three weeks of age in some markets.
Its single-dose oral regimen and activity against oseltamivir-resistant strains distinguish it from older antivirals such as Tamiflu and it is listed in the WHO clinical practice guidelines for influenza.
To facilitate the transition to generic production, Roche will provide sublicensees (in collaboration with MPP) with access to a foundational data package, reference products for bioequivalence studies and regulatory waivers.
Generic manufacturers will still be responsible for independently compiling and maintaining their own regulatory submissions, however.
MPP has launched an Expression of Interest to identify qualified manufacturers with the capacity to support development and supply under the licence.
The initiative targets both seasonal influenza management and broader pandemic preparedness, with the collaboration designed to ensure diversified manufacturing capacity is established before the next major influenza outbreak.
In the joint release, Charles Gore, Executive Director of MPP, said the agreement addressed a persistent gap in LMIC access to antivirals, where the burden of respiratory disease remains high.
Roche CEO Thomas Schinecker emphasised the role of voluntary licensing in enabling access while preserving the incentive structures that support future drug development.
The announcement comes as the single-source supply of baloxavir has drawn increasing scrutiny, with pharmacy-level stock shortages reported during the 2025–26 influenza season in the US.
Geographically distributed generic manufacturing across LMICs could reduce similar vulnerabilities globally.
Unitaid Executive Director Dr Philippe Duneton described voluntary licensing as a proven mechanism for shortening the path from innovation to access, particularly in lower-resource settings.