Aurobindo, Cadila Pharmaceuticals get nod to make generic version of Pfizer’s COVID medication

Aurobindo, Cadila Pharmaceuticals get nod to make generic version of Pfizer’s COVID medication

Aurobindo Pharma, Cadila Pharmaceuticals, and Torrent Pharmaceuticals said they had received a license to make a generic version of Pfizer's oral antiviral COVID 19 medication PAXLOVID and sell it in 95 countries, including India.

The companies received the nod after they signed a sub-licensing pact with Medicines Patent Pool MPP, a UN-based public health organisation that works to increase access to life-saving medicines for low and middle-income countries.

MPP had signed a voluntary licensing agreement with Pfizer for sub-licensing this COVID 19 treatment product to qualified generic drugmakers.

We are pleased to partner with MPP to make a generic version of the innovative medicine PAXLOVID for the global community and contribute to reducing the health burden due to the pandemic.

Cadila Pharmaceuticals CMD Rajiv Modi said in a statement that they reiterated their commitment to make affordable innovations available to the last man in society.

Cadila said it will cater to Indian and export markets because many countries with high COVID 19 burden don't have access to effective therapy.

Pfizer markets its oral COVID 19 treatment under the name PAXLOVID, which is authorised by the US Food and Drug Administration FDA for emergency use authorisation of EUA and the UK Medicines and Healthcare Products Regulatory Agency MHRA for the treatment of COVID 19 in patients at high risk of serious illness.

The USFDA was the first regulatory agency to approve use of PAXLOVID, nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use to treat high-risk mild-to moderate COVID- 19 adults and paediatric patients over 12 years of age weighing at least 40 kg.

'Aurobindo has already developed and commercialized ritonavir, which is used as a booster along with nirmatrelvir.

After due process of registration and approval in various countries including DCGI in India, Aurobindo Vice-Chairman and Managing Director K Nithyananda Reddy, we are excited to work on this molecule and will soon make it available at an affordable price for these markets.

Reddy said that this combination will be a very valuable addition to our portfolio along with Molnaflu molnupiravir for the treatment of COVID 19.

The company is able to control supply chain and cost efficiencies because it enjoys backward integration with in-house API manufacturing for nirmatrelvir and ritonavir molecules, like other antivirals, according to the company.

Torrent Pharmaceuticals has signed a non-exclusive, non-transferable, non-sub licensable licence agreement to use the patents and know-how in relation to the compound nirmatrelvir with MPP for the manufacture and commercialization of the generic version of PAXLOVID. This is to be co-administered and co-administered with ritonavir in 95 low and middle-income countries, including India, for the treatment and prevention of COVID 19 caused by SARSCoV 2.

Aman Mehta Executive Director Aman Mehta said: We are pleased to enter into this agreement with MPP and is part of our continuing endeavour to make COVID 19 treatments as accessible as possible for patients. The product is going to be launched after getting approval from regulatory agencies.