Eli Lilly Weight Loss Drug Zepbound No Longer in Shortage

The Food and Drug Administration (FDA) has announced that the active ingredient in Eli Lilly’s weight loss drug Zepbound, tirzepatide, is no longer in shortage. This decision will eventually bar compounding pharmacies from making cheaper, unbranded versions of the injection.

End of Shortage Status

The FDA’s decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could make, distribute, or dispense unapproved versions of tirzepatide without facing repercussions for violations related to the treatment’s shortage status. Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said that transition period will give patients time to switch to the branded version.

Impact on Compounding Pharmacies

The decision is a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes counterpart Mounjaro is.

Background

Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand. A trade organization representing compounding pharmacies, the Outsourcing Facilities Association, sued the FDA on October 8 over the agency’s decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists.

Compounded Medications

Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law. However, the FDA does not review the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are available.

Conclusion

The FDA’s decision to remove tirzepatide from its shortage list marks the end of a period where compounding pharmacies could make unapproved versions of the injection. While this decision may be a blow to some compounding pharmacies, it will give patients time to switch to the branded version of the drug.

Frequently Asked Questions

Q: What is tirzepatide?
A: Tirzepatide is the active ingredient in Eli Lilly’s weight loss drug Zepbound.

Q: Why is tirzepatide no longer in shortage?
A: The FDA has determined that the shortage of tirzepatide injection products is resolved.

Q: What does this mean for compounding pharmacies?
A: Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 days, depending on the type of facility.

Q: Why are some compounding pharmacies making copycat drugs?
A: Some compounding pharmacies say their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag.