19 Indian firms get licence to make Pfizer's oral generic

India Pharma Outlook Team | Friday, 18 March 2022

 India Pharma Outlook Team

The Medicines Patent Pool (MPP) has granted licences to 19 Indian pharmaceutical firms to manufacture and commercialise the generic version of Paxlovid, Pfizer's oral antiviral Covid-19 pill. These include Cipla, Sun Pharma, Laurus Labs, Divi's Laboratories, Glenmark, Emcure, Macleods, SMS Pharmaceuticals, Strides, Torrent, Cadila, Biocon, Aurobindo Pharma, Hetero, Granules, Amneal, and Viatris, among others.

MPP is a United Nations-backed public health organisation that is working to increase access to life-saving medicines for low- and middle-income countries. MPP had previously entered into a licence agreement with PF Prism Holdings BV (Pfizer), granting it the rights to sub-license to produce and commercialisation rights to sub-licensees. Pfizer's Paxlovid comprises nirmatrelvir, which inhibits a SARS

-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir's breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days.

It is a prescription-only drug and should be initiated as soon as possible after the diagnosis of Covid-19 and within five days of the onset of symptoms. Torrent Pharmaceuticals, Cadila Pharmaceuticals and Aurobindo Pharma established on Thursday that they had received licences from MPP.

"We are pleased to partner with MPP to make a generic version of Paxlovid for the global community and contribute towards reducing the health burden due to the pandemic," said Rajiv Modi, chairman and managing director of Cadila Pharmaceuticals said. The US Food and Drug Administration (FDA) had authorised the use of Paxlovid to treat high-risk mild-to-moderate Covid-19 in adults and children above 12 years of age and weighing at least 40 kg.

"We are thrilled to work on this molecule and will soon make it available commercially at an affordable price for these markets after due process of registration and approval in various countries including DCGI in India," said Nithyananda Reddy, managing director of Aurobindo Pharma.

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