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Inclusion of Indian manufacturers Laurus Labs Limited and MSN Laboratories in Medicines Patent Pool (MPP) voluntary licensing for influenza medication baloxavir marboxil (Xofluza) has added heft towards global pandemic preparedness, according to Lakshmi Prasanna, senior director, Pharmaceuticals Export Promotion Council of India (Pharmexcil).
Prassana further added that this development highlights India’s strength as a reliable global pharmaceutical manufacturing hub. Building manufacturing capacity and partnerships before the next health emergency will be crucial to strengthening supply resilience and ensure the timely access to essential medicines across Low- and Middle-Income Countries (LMICs).
The MPP announced sublicence agreements with 11 manufacturers across 9 countries to develop generic versions of baloxavir for pandemic preparedness at the 81st United Nations General Assembly (UNGA) meet.
According to an MPP spokesperson, “We have signed sublicence agreements to develop and manufacture generic versions of baloxavir marboxil, an innovative antiviral treatment for influenza, under MPP’s voluntary license with Roche. This diverse geographically network brings together global manufacturing capacity and regionally focused production across Brazil, China, India, Indonesia, Malaysia, Nigeria, Uganda, Ukraine and Vietnam — helping to strengthen supply resilience, support local and regional manufacturing, and enable faster access in future health emergencies.”
The MPP spokesperson further added that pandemic preparedness means acting before the next crisis hits. By putting partnerships, technical support and manufacturing capacity in place now, voluntary licensing can help ensure that LMICs are better positioned to access essential tools when they are needed most. We are grateful to Roche, Unitaid, the Swiss Agency for Development and Cooperation, and the 11 participating manufacturers for their collaboration and commitment to access.
Unitaid is a global health initiative hosted by the World Health Organization (WHO) in Geneva. It was founded in 2006 by Brazil, Chile, France, Norway, and the United Kingdom (UK).
Laurus Labs and MSN Laboratories are two Indian pharmaceutical companies that partnered with the MPP and Roche to manufacture generic versions of the influenza medication baloxavir marboxil (Xofluza). Laurus Labs and MSN are two of the four primary global-presence manufacturers selected to produce the generic medication. The sub-licensing terms are royalty-free for low-income countries and royalty-bearing (5% to 10% of net sales) for lower- and upper-middle-income countries.
Through the MPP, voluntary licensing works as a one-stop-shop public-health mechanism that bridges the gap between pharmaceutical innovators and generic drug manufacturers. Instead of requiring individual, complex bilateral negotiations between multiple companies, the process follows a structured, three-step public health model.
As per the core steps of the MPP Licensing Model, the originator grants a licence. A patent holder, such as a pharmaceutical corporation, university, or researcher, voluntarily shares the intellectual property (IP) rights of a patented medical technology or drug with the MPP. The UN-backed MPP negotiates public-health-driven, transparent terms. These terms define which LMICs can receive the drugs and outline any affordable royalty payments that will be sent back to the patent holder.
The MPP then issues non-exclusive sublicences to multiple qualified generic drug manufacturers simultaneously.
This process benefits global health by driving prices down through competition: Because sublicences are non-exclusive, multiple generic factories can produce the same drug. Healthy market competition drastically reduces costs, making treatments affordable for local governments and patients.
It simplifies combination drugs. For complex diseases, a patient might need a single pill that combines three separate patented drugs. Generic manufacturers can come straight to the MPP to get all the required licences at once, rather than tracking down three different corporate patent owners.
Manufacturers under the MPP umbrella must meet strict selection criteria and secure approvals from Stringent Regulatory Authorities (SRAs) like the WHO or US FDA. This prevents unauthorized drug diversion and guarantees that affordable medication remains safe and effective.
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