Amneal Awarded Sub-License to Manufacture and Commercialize Generic Version of Co-Packaged Nirmatrelvir and Ritonavir in 95 Low- and Middle-Income Countries
18 March 2022 - - US-based Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has been awarded a sub-license from the Medicines Patent Pool to manufacture and commercialize a generic version of nirmatrelvir, co-packaged with ritonavir, in 95 low- and middle-income countries, the company said.

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.

The phase 2/3 Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial conducted by Pfizer (NYSE: PFE) demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with Paxlovid, compared to placebo, within three days of symptom onset.

The US Food and Drug Administration granted Paxlovid emergency use authorization in December 2021. The product has been authorized or approved in many other countries as well.

To 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 US and India.

The global demand for generic versions of co-packaged nirmatrelvir and ritonavir is expected to be robust. Amneal is working to bring the co-packaged combination to these impacted countries starting in 2023.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, New Jersey, is a fully integrated essential medicines company.

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.