WHO Authorizes PAXLOVID, The First Oral COVID-19 Generic

The generic version of the COVID-19 oral antiviral therapy candidate nirmatrelvir has been approved by the World Health Organization Prequalification of Medicines Program (WHO PQ), as stated by the Indian pharmaceutical company Hetero.

This is the first prequalification for a generic form of PAXLOVID, an oral antiviral medicine manufactured by Pfizer and designated by the WHO as the best therapeutic option available for high-risk patients. Nirmatrelvir and ritonavir were strongly advised by the WHO for mild and moderate COVID-19 patients who were at the greatest risk of being admitted to the hospital, such as those who were immunosuppressed, elderly, or hadn’t had a vaccine.

Nirmatrelvir 150 mg (2 pills) and ritonavir 100 mg are both included in the combo pack, which Hetero is marketing as NIRMACOM (1 tablet). Only by prescription, it must be started within five days after the onset of symptoms and as soon as COVID-19 has been diagnosed. The production of NIRMACOM will take place at Hetero’s facilities in India.

In order to produce and market a generic version of Pfizer’s COVID-19 oral antiviral therapy candidate, nirmatrelvir, in low- and middle-income nations, Hetero engaged in a non-exclusive voluntary licencing agreement with Medicines Patent Pool.