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Amneal Awarded Sub-License to Manufacture and Commercialize Generic Version of Co-Packaged Nirmatrelvir and Ritonavir in 95 Low- and Middle-Income Countries
- One of 35 global companies selected to manufacture and commercialize generic version of COVID-19 treatment BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- One of 35 global companies selected to manufacture and commercialize generic version of COVID-19 treatment\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it 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.\n\nPfizer markets co-packaged nirmatrelvir and ritonavir in the United States and other countries as PAXLOVIDTM. The phase 2/3 Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial conducted by Pfizer demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVIDTM, compared to placebo, within three days of symptom onset. The U.S. Food and Drug Administration (FDA) granted PAXLOVIDTM emergency use authorization (EUA) in December 2021. The product has been authorized or approved in many other countries as well.\n\nTo increase equitable access for this therapy, 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. 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 U.S. and India.\n\n“Amneal has always held a deep commitment to provide access to affordable essential medicines and address unmet patient needs. This is a distinct opportunity for us to fulfill this mission on a global basis,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Nirmatrelvir and ritonavir have the potential to help address the pandemic in a way we have not seen before, and we are honored to contribute to the global manufacture and distribution of generic versions of these important therapies.”\n\n“As we grow our commercial business in India, we expect this will be an anchor product for us,” continued Messrs. Patel. “An...