Eli Lilly weight loss drug Zepbound is no longer in short supply

The Food and Drug Administration said Thursday that the active ingredient Eli Lilly’s The weight loss drug Zepbound is no longer missinga decision that will eventually prevent compounding pharmacies from making cheaper, unbranded versions of the injection.

“FDA has determined that the shortage of tirzepatide injection products, which began in December 2022, has been resolved,” the agency said in a letter. “The FDA continues to monitor the supply and demand for these products.”

The agency’s decision, based on a thorough analysis, marks the end of a period when certain pharmacies could manufacture, distribute or dispense unapproved versions of Zepbound’s active ingredient tirzepatide without facing repercussions for violations related to the treatment 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 the transition period will give patients time to switch to the brand-name version.

It’s a blow to some compounding pharmacies, which say its copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its high price tag of roughly $1,000 a month. Zepbound and other weight-loss drugs 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 compounding pharmacies and the FDA over shortages of tirzepatide, the active ingredient in both Zepbound and Mounjaro. Eli Lilly has it billions invested to expand its tirzepatide manufacturing capacity as it struggles to keep pace with unprecedented demand.

A trade organization representing compounding pharmacies—the Association of Outsourcing Facilities— sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its official drug shortage list just days earlier. The group alleges that the FDA acted without warning, ignoring evidence that a shortage of tirzepatide still exists. He also claimed that the FDA’s action was a coup for Eli Lilly at the expense of patients.

After the lawsuit, the FDA said it would reevaluate removing tirzepatide from the shortage list. That allowed compounding pharmacies to continue making knockoffs while the agency reviews its decision.

Compounded medications are customized alternatives to brand-name medications designed to meet a patient’s specific needs. When there is a shortage of a brand-name drug, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.

The Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency has urged consumers to take approved brand-name GLP-1 medications when available.

However, the FDA inspects some outsourcing facilities that include drugs, according to her web site.

Patients have turned to combination versions of tirzepatide amid intermittent shortages of brand-name drugs in the United States, which carry prices as high as $1,000 a month before insurance and other discounts. Many health plans do not cover tirzepatide for weight loss, making compounded versions a more affordable alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortage for the past two years. But the FDA earlier this month said all doses of these drugs are now available.

The agency has yet to announce whether it will remove semaglutide from its shortage list, a decision that would likely affect compounding pharmacies even more, since it is more widely used 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. Companies say so raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have stepped in to address illicit versions of their treatments. plaintiff weight loss clinics, medical spas, and compounding pharmacies in the US over the past year. The FDA last month also said yes reports received of patients taking an overdose of compound semaglutide due to dosing errors, such as patients self-administering incorrect amounts of a treatment.