Eli Lilly's weight loss drug Zepbound is no longer in short supply
An injection pen of Zepbound, Eli Lilly's weight loss drug, is on display in New York City on December 11, 2023.
Brendan McDermid | Reuters
The Food and Drug Administration said Thursday that it contained the active ingredient Eli Lilly's The weight-loss drug Zepbound is no longer in short supply, a decision that will ultimately prevent drug pharmacies from producing cheaper, unbranded versions of the shot.
“The FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, has been resolved,” the agency said in a letter. “The FDA continues to monitor supply and demand for these products.”
The agency's decision, based on a comprehensive 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 consequences for related violations Deficiency status of the treatment meant.
Pharmacies that make compounded drugs 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 the transition period will give patients time to switch to the branded version.
That's a blow to some pharmacies, which say their copycat drugs help patients who don't have insurance coverage for Zepbound and can't afford the high price of around $1,000 a month. Zepbound and other weight-loss medications aren't covered by many insurance plans, but Eli Lilly's diabetes counterpart Mounjaro is.
It's the latest in a high-stakes dispute between Pharmaceuticals and the FDA over a shortage of tirzepatide, the active ingredient in Zepbound and Mounjaro. Eli Lilly has invested billions to expand its production capacity for tirzepatide as the company struggles to keep up with unprecedented demand.
A trade group representing compounding pharmacies – the Outsourcing Facilities Association – sued the FDA on October 8 over the agency's decision to remove tirzepatide from its official list of drug shortages just days earlier. The group claims the FDA acted without adequate notice and ignored evidence that a shortage of tirzepatide still exists. She also claimed that the FDA's action was a coup for Eli Lilly at the expense of patients.
Following the lawsuit, the FDA said it would reconsider removing tirzepatide from the shortage list. This allowed pharmacies to continue producing copycats while the agency reviewed its decision.
Compounded medications are customized alternatives to brand-name medications tailored to the needs of a specific patient. When a brand-name drug is in short supply, pharmacies that manufacture drugs can make copies of the drug if they meet certain requirements of federal law.
The Food and Drug Administration does not review the safety and effectiveness of compounded products, and the agency has urged consumers to take the approved brand-name GLP-1 medications when they become available.
However, according to its website, the FDA inspects some outsourcing facilities that make drugs.
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Patients are turning to compounded versions of tirzepatide because of intermittent shortages of the brand-name drugs in the U.S., which come with high prices of $1,000 a month without insurance and other discounts. Many health insurance companies do not cover the cost of tirzepatide for weight loss, making compounded versions a cheaper alternative.
The active ingredient in Wegovy and Ozempic, semaglutide, has experienced temporary shortages over the past two years. But the FDA said earlier this month that all doses of those drugs are now available.
The agency has not yet announced whether it will remove semaglutide from its shortage list – a decision that would likely affect even more drug pharmacies because it is used more commonly than tirzepatide.
Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection in the United States and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients of their drugs to outside groups. The companies say this raises questions about what some manufacturers are selling and marketing to consumers.
Novo Nordisk and Eli Lilly have both stepped up to crack down on illegal versions of their treatments, suing weight-loss clinics, medical spas and prescription pharmacies in the US last year. The FDA also said last month that it had received reports of patients overdosing on compound semaglutide due to dosing errors, such as patients self-administering incorrect amounts of treatment.
