The Biden administration must use executive action to lower the price of Paxlovid.

picture of medicine PaxlovidPaxlovid (nirmatrelvir and ritonavir) is a COVID-19 antiviral sold by Pfizer. The U.S. government has ordered 20 million courses for $530 per course. (1) While Pfizer expects to ramp up global production to 120 million courses by the end of the year, this may represent a fraction of estimated global patient need. (2) Smaller generic firms have developed their own versions of the drug for less than half the price, although none have so far been shown to meet stringent regulatory requirements in other countries. (3) At least thirty generic suppliers are expected to produce Paxlovid for global supply. (4)

However, Paxlovid is currently in shortage in the U.S. The federal government has so far received less than 1 million doses from Pfizer. (5) Pfizer supply is expected to pick up later in the year, but the U.S. may still not have enough. For example, if the 20 million courses ordered by the U.S. government continue to be distributed on a pro rata basis among 50 states, then the allocations will average 400,000 courses per state. (6) Scarcity will make distribution more difficult, particularly as much remains unknown about the course of the virus and its potential severity this winter. Scarcity may also limit the success of the test-to-treat initiative recently announced by the Biden administration.

One of the key components in Paxlovid, nirmatrelvir, is new. As such, there have been no patents granted yet on the drug, although many patent applications have been filed around the world, which will discourage generic entry. Certainly, the generic manufacturers coming online are not currently planning investments with the U.S. market in mind. Pfizer retains a de facto monopoly.

The U.S. government can expand access to affordable supply by signaling that it will use generic supply so long as it can meet FDA requirements. For example, the U.S. government can provide a letter authorizing generic manufacturers for government procurement, thereby providing the shield of Section 1498 if and when patent applications mature into issued patents. In doing so, the U.S. government can reduce prices, increase supply, and help protect more Americans from COVID-19.

(1) Biden Administration Secures 10 Million Courses of Pfizer’s COVID-19 Oral Antiviral Medicine as Additional Tool to Reduce Hospitalizations and Save Lives |
(6) “An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December. Initial allocations of Paxlovid were determined on a pro rata basis and will be provided to state and territorial health departments for free.”