Amneal to Manufacture Generic Version of Paxlovid to Treat COVID-19

Amneal Pharmaceuticals has been awarded a sub-license from the Medicines Patent Pool (MPP) to manufacture and commercialize a generic version of nirmatrelvir, co-packaged with ritonavir, in 95 low- and middle-income countries. Nirmatrelvir is an oral protease inhibitor co-packaged with ritonavir for the treatment of mild-to-moderate COVID-19.

Pfizer markets co-packaged nirmatrelvir and ritonavir in the United States and other countries as Paxlovid, was which granted an emergency use authorization by the FDA in December 2021 to treat mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older. Pfizer also has emergence use authorization for Paxlovid in the European Union.

Pfizer has entered into a license agreement with the MPP to sub-license the manufacture of generic versions of nirmatrelvir, as well as the commercialization of co-packaged nirmatrelvir and ritonavir, to multiple pharmaceutical companies committed to providing the product to 95 low- and middle-income countries. This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years. Pfizer executives said the company will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency,

Amneal plans to manufacture nirmatrelvir in India and already owns an internally developed, FDA-approved generic version of ritonavir, which will be manufactured in both the United States and India. Amneal is working to bring the co-packaged combination to these impacted countries starting in 2023.