Eli Lilly weight loss drug Zepbound no longer in shortage

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

“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 the supply and demand for these products.”

The agency’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 — the active ingredient in Zepbound — without facing repercussions for violations related to the treatment deficiency state.

The agency said compounding pharmacies will have to stop making compounded versions of tirzepatide 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 brand-name version.

That’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 about $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes man, Mounjaro, is.

It is the latest in a high-profile dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in Zepbound and Mounjaro. Eli Lilly has invested billions to expand its tirzepatide manufacturing capacity as it struggles to keep up with unprecedented demand.

A trade organization representing compounding pharmacies – the Association of Outsourcing Facilities – sued the FDA on Oct. 8 about the agency’s decision to remove tirzepatide from its official drug shortage list a few days earlier. The group claims that the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists. He also said the FDA’s action was a blow to Eli Lilly that came at the expense of patients.

Following the suit, the FDA said it would reevaluate the removal of tirzepatide from the shortage list. That allowed compounding pharmacies to continue making copies while the agency reviewed its decision.

Compounded medications are customized alternatives to brand name drugs designed to meet the needs of a specific patient. When a brand-name medication is in short supply, compounding pharmacies can prepare copies of the drug if it meets 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 compound drugs, according to its knowledge website.

Patients have turned to compounded versions of tirzepatide amid intermittent shortages of the brand-name drug in the United States, which carry a hefty price tag of $1,000 a month before insurance and other reimbursements. Many health plans do not cover tirzepatide for weight loss, making compounded versions a cheaper alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. But the FDA earlier this month said that 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 will likely affect even more compounding pharmacies 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 provide the active ingredients in their drugs to outside groups. Companies say that raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have both stepped in to tackle illicit versions of their treatments, sucking weight loss clinics, medical spas and compounding pharmacies in the United States over the past year. The FDA last month also said it had reports received of patients overdosing on compound semaglutide due to dosing errors, such as patients self-administering incorrect amounts of treatment.