The United Nations-backed Medicines Patent Pool (MPP) plans to name the generic drugmakers that are going to make Generic Paxlovid pills next week, four months after reaching a licensing agreement with Pfizer.

However, some parts of the world may have to wait longer for the drug because of production and regulatory hurdles, according to Bloomberg.

It is expected that companies may get ready to supply the Generic Paxlovid pills by the end of this year, according to MPP. However, Airfinity Ltd., a UK-based global health intelligence and analytics firm, estimates that larger quantities of the drug may only reach the market by May 2023.

Clinical trials have found that Paxlovid reduced the risk of hospitalization or death by almost 90%. Some high-income countries have secured about 25% of Pfizer’s initial supplies, which is increasing pressure on the company and others to accelerate the distribution of the drug in middle- and lower-income nations.

Rachel Cohen, Regional Executive Director of the Drugs for Neglected Diseases initiative (DNDi), said, “It’s a potential game-changer, but not if we accept a two-tier system. We cannot accept these obstacles as static. It has to be an issue around which people mobilize.”

Kit Longley, Senior Manager of Science Media Relations at Pfizer, said, the company is “focusing our efforts and resources in a way that maximizes our overall supply,” adding that it is collaborating with the World Health Organization (WHO) to share information about its treatment, pricing, and supplies.

Public information about Paxlovid has been relatively limited. Plus, companies have had to wait for licenses and Pfizer’s original product to become available, according to MPP.

The drug may take time to enter some nations because of certain hurdles and complexities, including drug regulatory approvals and demonstrating the drug can maintain its properties over time, according to Charles Gore, MPP’s Executive Director.

He said, “It’s not fair to have expectations that these things can be done overnight. They just can’t.”

Meanwhile, Pfizer has been taking steps to broaden the availability of Paxlovid. Apart from signing an agreement and promising it will not receive royalties from sales in low-income countries, the pharma giant said that it will use a tiered-pricing system in which richer countries pay more.

Pfizer has raised its production estimate for Paxlovid to 120 million doses. It plans to deliver 20 million to the U.S. this year. Airfinity said the U.K. purchased about 2.75 million and another 10 million courses could go to lower-income countries.