Eli Lilly’s weight loss drug “Zepbound” eliminates shortage

The Food and Drug Administration announced Thursday that it contains the following active ingredients: Eli Lilly’s The weight-loss drug Zepbound is no longer in short supply, and the decision will ultimately ban pharmacies from producing the cheaper, off-brand injectables.

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

The agency’s decision, based on a comprehensive analysis, indicates that certain pharmacies cannot manufacture, distribute, or sell unapproved versions of tirzepatide, the active ingredient in Zepbound, without being subject to violations related to drug shortage situations. This marks the end of the period in which the drug can be dispensed.

The agency said compounding pharmacies must stop manufacturing tirzepatide combinations within the next 60 to 90 days, depending on the type of facility. The FDA said the transition period will give patients time to switch to the branded version.

This is a blow to some pharmacies, which say the counterfeit drugs are helping patients who don’t have Zepbound’s insurance and can’t afford the high drug prices, which cost about $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes drug Mounjaro is covered by insurance plans.

This is the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Mounjaro. Eli Lilly has invested billions of dollars to expand manufacturing capacity for tirzepatide as the company struggles to meet unprecedented demand.

The Outsourcing Facilities Association, a trade group representing compounding pharmacies, sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from the official drug shortage list days earlier. The group claims the FDA acted without proper notice and ignored evidence that a tirzepatide shortage still exists. They also argued that the FDA’s actions were a coup d’état by Eli Lilly at the expense of patients.

In response to the lawsuit, the FDA announced it would reevaluate whether to remove tirzepatide from its shortage list. This allowed pharmacies to continue manufacturing counterfeit products while authorities considered the decision.

Compounded medicines are custom-made alternatives to branded medicines, designed to meet specific patient needs. When a brand-name drug is in short supply, compounding pharmacies can make copies of the drug if they meet certain requirements under federal law.

The Food and Drug Administration does not review compounded products for safety and effectiveness and urges consumers to take approved branded GLP-1 drugs when they become available.

However, the FDA inspects some outsourcing facilities that compound drugs, according to its website.

Amid intermittent shortages of brand-name drugs in the U.S., patients are turning to combination versions of tirzepatide, which come with a hefty price tag of $1,000 a month before insurance and other rebates. Many health insurance plans do not cover tirzepatide for weight loss purposes, making the combination version a more affordable alternative.

Semaglutide, the active ingredient in Wegovy and Ozempic, has been in intermittent shortages for the past two years. However, the FDA announced earlier this month that all doses of these drugs are now available.

The agency has not yet announced whether it will remove semaglutide from the shortage list, but since semaglutide is more widely used than tirzepatide, the decision is likely to affect even more compounding pharmacies.

Wegovy, Ozempic, Zepbound and Mounjaro are protected by patents 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 in to address their illegal treatments, suing weight loss clinics, medical spas, and pharmacies across the United States over the past year. The FDA announced last month that it had received reports of patients overdosing on combination semaglutide due to dosing errors, such as patients self-administering the wrong amount of the treatment.