FDA Authorizes Shelf-Life Extension for REGEN‑COV From 24 months to 30 Months
June 27, 2022
Therapeutic Updates
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.
On June 27, 2022, FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV (see Table 1, Table 2, and Table 3 below). Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized
Fact Sheet for Health Care Providers and the
Letter of Authorization for Emergency Use Authorization (EUA) 091.
These recommendations apply to all unopened vials of casirivimab, imdevimab, and REGEN-COV that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C [36°F to 46°F]) detailed in the authorized Fact Sheet for Health Care Providers for EUA 091 for casirivimab and imdevimab, administered together. Please contact
COVID19Therapeutics@hhs.gov with any questions.
Table 1: Extended Expiry Dating for Individually Cartoned Vials of Casirivimab and Imdevimab (REGEN-COV) Authorized under EUA 91
Table 1a: Individually Cartoned Casirivimab Vialsb
Table 1b: Individually Cartoned Imdevimab Vialsb
Vial Batch Numbera |
Labelled Expiry Date |
Extended Expiry Date |
8364300003c |
31-Aug-2022 |
28-Feb-2023 |
8364300004c |
31-Aug-2022 |
28-Feb-2023 |
8364300005 |
31-Aug-2022 |
28-Feb-2023 |
8364300008 |
30-Sep-2022 |
31-Mar-2023 |
8364300007 |
30-Sep-2022 |
31-Mar-2023 |
8364300006 |
30-Sep-2022 |
31-Mar-2023 |
8364300011 |
30-Sep-2022 |
31-Mar-2023 |
8364300010 |
31-Oct-2022 |
30-Apr-2023 |
8364300009 |
31-Oct-2022 |
30-Apr-2023 |
8365500002c |
30-Jun-2022 |
31-Dec-2022 |
8365500004c |
31-Jul-2022 |
31-Jan-2023 |
8390800002 |
31-Oct-2022 |
30-Apr-2023 |
8390800003 |
31-Oct-2022 |
30-Apr-2023 |
8390800001 |
31-Oct-2022 |
30-Apr-2023 |
8390800004 |
31-Dec-2022 |
30-Jun-2023 |
8390800005 |
31-Dec-2022 |
30-Jun-2023 |
8390800006 |
31-Mar-2023 |
30-Sep-2023 |
8390800007 |
31-Mar-2023 |
30-Sep-2023 |
aBatch number represents the number printed on the vial for individually cartoned and dose-packed casirivimab and imdevimab.
bSome of the batches provided as individually cartoned vials were also included in dose-packs. Expiration date for dose-packs is based on the shortest expiry of all individually cartoned vials included in the dose-pack.
cExpiration date not printed on the carton.
Table 2: Extended Expiry Dating for Dose-Packed REGEN-COV Authorized under EUA 91
Dose-pack Batch Number |
Labelled Expiry Date
a |
Extended Expiry Date
a |
8409400029 |
30-Jun-22 |
31-Dec-22 |
8409400031 |
30-Jun-22 |
31-Dec-22 |
8409600003 |
30-Jun-22 |
31-Dec-22 |
8409400026 |
31-Jul-22 |
31-Jan-23 |
8409600001 |
31-Jul-22 |
31-Jan-23 |
8409600002 |
31-Jul-22 |
31-Jan-23 |
8409500006 |
31-Aug-22 |
28-Feb-23 |
8409500001 |
30-Sep-22 |
31-Mar-23 |
8409500002 |
30-Sep-22 |
31-Mar-23 |
8409500003 |
30-Sep-22 |
31-Mar-23 |
8409500004 |
30-Sep-22 |
31-Mar-23 |
8409500005 |
30-Sep-22 |
31-Mar-23 |
8409500007 |
30-Sep-22 |
31-Mar-23 |
8409400001 |
31-Oct-22 |
30-Apr-23 |
8409400002 |
31-Oct-22 |
30-Apr-23 |
8409400003 |
31-Oct-22 |
30-Apr-23 |
8409400005 |
31-Oct-22 |
30-Apr-23 |
8409400006 |
31-Oct-22 |
30-Apr-23 |
8409400007 |
31-Oct-22 |
30-Apr-23 |
8409400008 |
31-Oct-22 |
30-Apr-23 |
8409400009 |
31-Oct-22 |
30-Apr-23 |
8409400010 |
31-Oct-22 |
30-Apr-23 |
8409400011 |
31-Oct-22 |
30-Apr-23 |
8409400012 |
31-Oct-22 |
30-Apr-23 |
8409400013 |
31-Oct-22 |
30-Apr-23 |
8409400014 |
31-Oct-22 |
30-Apr-23 |
8409400015 |
31-Oct-22 |
30-Apr-23 |
8409400016 |
31-Oct-22 |
30-Apr-23 |
8409400017 |
31-Oct-22 |
30-Apr-23 |
8409400018 |
31-Oct-22 |
30-Apr-23 |
8409400019 |
31-Oct-22 |
30-Apr-23 |
8409400020 |
31-Oct-22 |
30-Apr-23 |
8409400021 |
31-Oct-22 |
30-Apr-23 |
8409400022 |
31-Oct-22 |
30-Apr-23 |
8409400023 |
31-Dec-22 |
30-Jun-23 |
8409400024 |
31-Dec-22 |
30-Jun-23 |
8409400025 |
31-Dec-22 |
30-Jun-23 |
8409400027 |
31-Dec-22 |
30-Jun-23 |
8409400028 |
31-Dec-22 |
30-Jun-23 |
8409400032 |
31-Dec-22 |
30-Jun-23 |
8409400033 |
31-Dec-22 |
30-Jun-23 |
aExpiration date for dose-packs is based on the shortest expiry of all individually cartoned vials included in the dose-pack.
Table 3: Extended Expiry Dating for Co-packaged REGEN-COV Authorized under EUA 91
Batch Numbera |
Labelled Expiry Date |
Extended Expiry Date |
N7561B05 |
Dec 2022 |
Jun 2023 |
N7568B03 |
Dec 2022 |
Jun 2023 |
N7561B03 |
Dec 2022 |
Jun 2023 |
N7568B01 |
Dec 2022 |
Jun 2023 |
N7568B02 |
Dec 2022 |
Jun 2023 |
N7578B05 |
May 2023 |
Nov 2023 |
N7578B06 |
May 2023 |
Nov 2023 |
N7561B02 |
Dec 2022 |
Jun 2023 |
N7561B04 |
Dec 2022 |
Jun 2023 |
N7568B04 |
Dec 2022 |
Jun 2023 |
N7567B04 |
Apr 2023 |
Oct 2023 |
N7589B01 |
Jun 2023 |
Dec 2023 |
N7589B02 |
Jun 2023 |
Dec 2023 |
N7606B02 |
Jun 2023 |
Dec 2023 |
N7589B03 |
Jun 2023 |
Dec 2023 |
N7582B01 |
May 2023 |
Nov 2023 |
N7582B02 |
May 2023 |
Nov 2023 |
N7589B04 |
Jun 2023 |
Dec 2023 |
N7601B01 |
Jun 2023 |
Dec 2023 |
N7601B02 |
Jun 2023 |
Dec 2023 |
N7601B03 |
Jun 2023 |
Dec 2023 |
aFor co-packaged material, the batch number represents the number printed on the carton