An injection pen for Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City on Dec. 11, 2023.
Brendan McDermid Reuters
The Food and Drug Administration reported this information on Thursday Eli Lilly There is no longer a shortage of the weight-loss drug Zepbound, a decision that will eventually prevent complex pharmacies from making cheaper, unbranded versions of the injection.
“FDA has determined that the shortage of tergepeptide injection products, which first began in December 2022, has been resolved,” the agency said in a letter. “FDA continues to monitor the supply and demand for these products.”
The agency’s decision, based on an extensive analysis, marks the end of a period in which certain pharmacies could manufacture, distribute or dispense unapproved versions of tirzepatide — the active ingredient in Zepbound — without facing repercussions for violations related to medical shortage conditions.
Compounding pharmacies must stop making compounded versions of tirzepatide within the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said the transition period will give patients time to switch to the branded version.
That’s a setback for some complex pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for the jabbound and can’t afford the hefty price tag of about $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.
It’s the latest in a high-profile dispute between compounding pharmacies and the FDA over shortages of tirzepetide, the active ingredient in both Zepbound and Eli Lilly’s diabetes treatment Mounjaro. Eli Lilly has invested billions to expand its production capacity for tirzeptide to keep up with unprecedented demand.
A trade organization representing compounding pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 days before the agency’s decision to remove tirzepatide from its official drug shortage list. The group alleged that the FDA acted without proper notice, ignoring evidence that shortages of tergepeptides still existed. It also argued that the FDA’s move was a coup for Eli Lilly that came at the expense of patients.
Following the lawsuit, the FDA said it would reevaluate removing tirzepatide from the deficiency list. It allows compounding pharmacies to continue making copycats while the agency reviews its decision.
Compounded medicines are custom-made alternatives to branded medicines designed to meet a specific patient’s needs. When a brand-name drug is in short supply, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.
The US Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency urges consumers to take approved, branded GLP-1 medications when available.
However, the FDA inspects some outsourcing facilities that compound drugs, according to its website.
Amid a shortage of branded drugs in the U.S., patients are turning to the compounded version of tirzepatide, which carries a hefty price tag of $1,000 a month before insurance and other discounts. Many health plans do not cover tirzepetide for weight loss, making compounded versions a more affordable option.
The active ingredient in Wegovi and Ozempic, semaglutide, has been in intermittent shortages for the past two years. But the FDA said earlier this month that all doses of the drug are now available.
The agency has not yet announced whether it is removing semaglutide from its shortage list — a decision that will likely affect more complex pharmacies because it is more commonly used than tirzepatide.
Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection in the US and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients of their drugs to outside groups. The companies say some manufacturers question what they are selling and marketing to consumers.
Both Novo Nordisk and Eli Lilly have taken steps to combat illegal versions of their treatments, suing weight loss clinics, medical spas and compounding pharmacies in the US over the past year. The FDA also said last month that it has received reports of overdoses of the compound semaglutide in patients due to dosing errors such as self-administration of the wrong amount of treatment.
