Major drugmakers Cadila Pharmaceuticals, Aurobindo Pharma and Torrent Pharmaceuticals said Thursday they have received a license to make a generic version of Pfizer's oral COVID-19 antiviral drug PAXLOVID and sell it in 95 countries, including India.
The companies received the go-ahead after signing a sublicensing pact with the Medicines Patent Pool (MPP), a UN-based public health organization that works to increase access to life-saving medicines in low- and middle-income countries.
Previously, MPP had entered into a voluntary license agreement with Pfizer to sublicense this COVID-19 treatment product to qualified generic drug manufacturers.
โWe are pleased to partner with MPP to make a generic version of the innovative drug PAXLOVID for the global community and help reduce the health burden due to the pandemic.
"We reiterate our commitment to making affordable innovations available to the last man in society," CMD Rajiv Modi of Cadila Pharmaceuticals said in a statement.
Cadila said it will cater to the Indian and export markets as many countries with a high burden of COVID-19 lack access to effective therapy.
Pfizer markets its oral COVID-19 treatment under the name PAXLOVID, which is authorized by the US Food and Drug Administration (FDA) for emergency use authorization (EUA) and the Medicines and Products Regulatory Agency UK Health Services (MHRA) for the treatment of COVID-19. 19 in patients at high risk of progressing to severe disease.
The USFDA was the first regulatory agency to authorize the use of PAXLOVID, nirmatrelvir tablets, and ritonavir tablets, packaged together for oral use to treat adult and pediatric patients 12 years of age and older weighing up to minus 40 kg.
''Aurobindo has already developed and commercialized ritonavir, which is used as a booster together with nirmatrelvir.
"We are excited to work on this molecule and will soon make it commercially available at an affordable price for these markets after due process of registration and approval in several countries including DCGI in India," said Aurobindo Vice President and General Manager K. Nithyananda. reddish.
Reddy added that this combination will be a very valuable addition to our portfolio alongside Molnaflu (molnupiravir) for the treatment of COVID-19.
For nirmatrelvir and ritonavir molecules, like other antivirals, the company enjoys backward integration with in-house API manufacturing, providing it with stronger supply chain control and cost efficiency, the company said. .
Torrent Pharmaceuticals noted that it has entered into a non-exclusive, non-transferable, non-sublicensable license agreement to use the patents and know-how relating to the compound nirmatrelvir with MPP for the manufacture and marketing of the generic version of PAXLOVID. It will be co-packaged and administered with ritonavir in 95 low- and middle-income countries, including India, for the treatment or prevention of COVID-19 caused by SARSCoV-2.
Commenting on the agreement, Aman Mehta (Chief Executive Officer) said, "We are pleased to enter into this agreement with MPP and it is part of our ongoing effort to make COVID-19 treatments as accessible as possible for patients." release the product after obtaining the necessary approval from regulatory agencies.
