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

On Thursday, the Food and Drug Administration announced the active ingredient Eli Lilly’s weight loss drug is Zepbound there is no longer a shortagea decision that would ultimately prevent compounding pharmacies from making cheaper, off-brand versions of the injection.

“FDA has determined that the shortage of tirsepatide injectable products, which 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 review, marks the end of an era when certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide — the active ingredient in Zepbound — without facing repercussions for violations of treatment shortage status.

The agency said the compounding pharmacies must 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 branded version.

That’s a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for Zepbound 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.

It’s the latest in a high-stakes dispute between pharmacies and the FDA over shortages of tirzepatide, the active ingredient in both Zepbound and Mounjaro. There’s Eli Lilly invested billions to expand production capacity for tirzepatide as it struggles to keep up with unprecedented demand.

Trade organization representing complex pharmacies – Association of Outsourcing Facilities – sued The FDA on Oct. 8 followed the agency’s decision to remove tirsepatide from its official drug shortage list a few days earlier. The group claims the FDA acted without proper notice, 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 deficiency list. This allowed the compounding pharmacies to continue copying while the agency considered the decision.

Generic drugs are custom-made alternatives to brand-name drugs designed to meet the needs of a particular patient. When a brand of drug is in short supply, compounding pharmacies 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 efficacy of compounded products, and the agency does not urged consumers taking approved, branded GLP-1 medications when available.

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

Amid an intermittent U.S. shortage of the brand-name drug, which carries price tags as high as $1,000 a month before insurance and other rebates, patients have turned to compounded versions of tirzepatide. Many health plans do not cover tirezapatide for weight loss, making compounded versions a more affordable alternative.

Semaglutide, the active ingredient in Wegovy and Ozempic, has been in continuous shortage for 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 deficiency list — a decision that will affect more compounding pharmacies because tirzepatide is more widely used.

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 parties. This is what companies say raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have both launched efforts to address illegal versions of their treatments. to sue Weight loss clinics, medical spas, and compounding pharmacies in the United States over the past year. The FDA said it did last month, too received reports Patients with compound semaglutide overdoses due to dosing errors, such as patients who self-administer incorrect amounts of treatment.