Lagevrio Prepares for Transition to Commercial Distribution
September 29, 2023
COVID-19 Therapeutic Product Expiration Dates Database for the most recent shelf-life extension and product expiration information.
The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our
full list of updates.
The Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is committed to ensuring timely and transparent communication regarding the transition of COVID-19 treatments to the traditional commercial process. We anticipate that the transition of Lagevrio from government-managed distribution to traditional commercial distribution will occur in November 2023.
Lagevrio (molnupiravir) is an oral antiviral medication authorized by the FDA under an Emergency Use Authorization (EUA) for the treatment of adults with a current diagnosis of mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
As November approaches, the U.S. government will wind down its distribution of Lagevrio to maximize use of the government-purchased supply already positioned at dispensing locations around the country. Beginning October 2, HHS will move away from the current threshold/replenishment process to a request-based approach using the current out-of-cycle request process. Thresholds for all entities will be set to zero (0) for the month of October. Partners who need additional supply of Lagevrio will be able to order once an out-of-cycle request has been processed. This process will remain in place through early to mid-November. At that time, ordering from the government-purchased supply will close for Lagevrio. The product will be available for commercial purchase in November. We are working with our partners to ensure that people who are uninsured or underinsured continue to have access to this medication. The Merck Patient Assistance Program (a 501c3 Foundation) intends to provide Lagevrio free of charge to eligible patients who, without assistance, could not otherwise afford the product.
As a reminder, any supply that the government distributes must remain available to patients for free. Please continue to leverage the government-purchased supply in your inventory through its depletion or until expiry, whichever comes first. The government-procured supply has a distinct National Drug Code (NDC) from the EUA-labeled supply that will be distributed through commercial channels. The first lots of government-purchased Lagevrio will begin expiring in February 2024 and the last in February of 2025; please continue to check the
ASPR searchable expiry database for specific expiration dates.
Before prescribing Lagevrio, providers should read the
Fact Sheet for Healthcare Providers, including Mandatory Requirements for Administration of Lagevrio Under Emergency Use Authorization. The FDA Letter of Authorization and the Fact Sheet for Patients and Caregivers are also available.
At ASPR, we are committed to working as a true partner with state and local health officials and health care providers. Thank you for your steadfast collaboration on COVID-19 therapeutics over the past three years. Your efforts continue to protect the health of our nation from COVID-19 and the myriad of other infectious diseases our communities face every day.