Therapeutics Information for Providers

Latest Updates

Feb. 1: EUA-labeled Paxlovid authorization ends March 8th, 2024

The FDA has made an update to the Paxlovid Emergency Use Authorization (EUA) stating that the EUA-labeled Paxlovid distributed by the U.S. government (USG) will remain authorized for use only through March 8, 2024, regardless of the labeled or extended expiration date. 

Sites are encouraged to return all EUA-labeled Paxlovid to help USG earn a credit for use in the USG Patient Assistance Program. The program will provide free, NDA-labeled Paxlovid for Medicare, Medicaid and uninsured patients. The deadline to return EUA-labeled Paxlovid has been extended to Feb. 29, 2024.

As a reminder, commercial NDA-labeled Paxlovid is widely available for purchase through wholesalers.

View Previous Updates

Product Summaries

Brand Name Also Known As Authorized Indication Allocation Request Deadline Reporting Cadence (for USG-Supplied Product only)* EUA Fact Sheets Site Finder Shelf-Life Extension Information
Lagevrio Molnupiravir Treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization within 5 days of symptoms  Ordering for USG-supplied Lagevrio closed Nov. 10, 2023. Lagevrio is available commercially through wholesalers. Twice monthly, on the 15th and last day of the month by 11:59 p.m. in HPOP*

Molnupiravir  
Provider Fact Sheet

Molnupiravir  
Patient Fact Sheet

NCDHHS Treatments locator tool
Paxlovid Nirmatrelvir / Ritonavir, Pfizer Treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization within 5 days of symptoms Ordering for USG-supplied Paxlovid closed Dec. 15, 2023. Paxlovid is available commercially through wholesalers. Twice monthly, on the 15th and last day of the month by 11:59 p.m. in HPOP*

Paxlovid  
Provider Fact Sheet

Paxlovid  
Patient Fact Sheet

NCDHHS Treatments locator tool

 

*All providers with USG-supplied product should continue to report in HPOP until all inventory is either dispensed or expired. Reporting of commercially purchased products is voluntary.

Paxlovid Clinical Resources

Previous Updates

Tab/Accordion Items

Ordering for government-distributed oral antivirals closed Dec. 15, 2023. Paxlovid and Lagevrio are available commercially through wholesalers.

Using/Returning USG-distributed Product

  • Paxlovid: Providers are encouraged to follow the Paxlovid returns process to return excess product expiring December 2023 or later. Return by Jan. 31, 2024, to help USG earn a credit for use in the USG Patient Assistance Program. The program will provide free, NDA-labeled Paxlovid for Medicare, Medicaid and uninsured patients.
  • Lagevrio: Use until depleted or expired, whichever comes first.

More information: COVID-19 treatments transition operational guide

COVID-19 oral antiviral treatments, Paxlovid and Lagevrio, will be available for commercial purchase on Nov. 1, 2023. The current government distribution process will continue beyond Nov. 1 for both products to allow the commercial pipeline to mature and ensure there are no gaps in access. To prepare for the transition of these products from a government-managed distribution process to traditional commercial distribution, the U.S. Department of Health and Human Services has prepared a COVID-19 treatments transition operational guide with target dates and detailed information for each step in the transition process.

Staying up to date with vaccines and timely access to treatment are the best ways to reduce hospitalization and death due to COVID-19. This memo provides updated guidance for healthcare providers about outpatient treatment of COVID-19 and includes key treatment messages, information about product accessibility, and an overview of treatment options. Read the memo.

The FDA has authorized shelf-life extensions for the oral antivirals, Paxlovid and Lagevrio. Please check for these extensions before wasting product.

Effective Jan. 26, 2023, Evusheld is no longer authorized for prevention of COVID-19 in individuals who are immunocompromised. Based on the latest CDC data, Evusheld is unlikely to be active against more than 90% of the SARS-CoV-2 variants currently circulating in the U.S.  HHS and AstraZeneca have paused distribution of Evusheld until further notice by the Agency.

People who are immunocompromised, older adults, and people with disabilities continue to face increased risks from COVID-19. Individuals for whom COVID-19 vaccination is recommended should get vaccinated with the primary series and an updated vaccine when eligible to increase protection against the most serious consequences of COVID-19.

Treatment with Paxlovid or Lagevrio is widely available at pharmacies, Test to Treat sites, long-term care facilities, and other sites across the state. Learn more about treatment options that are expected to retain activity against COVID-19. The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future.

Have questions? We're here to help. 

Contact the Testing and Therapeutics team at covid19testingandtreatments@dhhs.nc.gov.