WHO approves generic Paxlovid drug for covid treatment in low-income countries

The generic version of Paxlovid, the Pfizer-made antiviral drug that is the best treatment choice for patients at risk of developing severe covidwill soon be available in low-and middle-income countries.

The World Health Organization (WHO) gave preapproval on Dec. 26 to Hetero, an Indian pharmaceutical company, for nirmacom, the generic version of Paxlovid. Like the brand name, the generic is comprised of two drugs: nirmatrelvir and ritonavir (a drug previously used for HIV that reduces the amount of virus circulating in the affected body).

Paxlovid has been available for a little over a year in the US, but limited supplies, approval delays, and high prices have kept it out of reach for many low- and middle-income countries.

A Medicines Patent Pool agreement

Hetero entered an agreement to produce its generic version of Paxlovid through Medicines Patent Pool (MMP), a UN-backed public health organization originally created to provide access to HIV medications outside of rich countries. MMP negotiates patent rights with big pharmaceutical companies, and facilitates the availability of their drugs for non-exclusive production by manufacturers willing to sell them in low- and middle-income nations.

In 2021, Pfizer agreed to make Paxlovid available for generic production through MMP, without charging royalties. For the next nine months, several drugmakers around the world worked to produce a generic version. Hetero is only the first to receive preapproval from the WHO, which guarantees quality control during production. The drug has already received emergency use authorization in India, and Hetero says it plans to make it available for purchase in 95 countries.

zenara pharmaanother Indian drugmaker, has also received emergency use approval in India for its generic version of Paxlovid. The company has yet to disclose the price of the drug, which cost the US government $530 a course in 2022 for the Pfizer version.

Nirmacom will be manufactured in Hetero’s facilities in India and available with prescription. As with Paxlovid, the course should be initiated by patients within five days of the onset of symptoms.