Eli Lilly weight loss drug Zepbound no longer in shortage

The Food and Drug Administration said Thursday that the active ingredient in Eli Lilly’s The weight-loss drug Zepbound is no longer in shortage, a move that will eventually ban specialty pharmacies from making cheaper, unbranded versions of the injection.

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

The agency’s decision, based on extensive analysis, marks the end of a period when some pharmacies could manufacture, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations. linked to the state of shortage of treatment.

Pharmaceutical pharmacies must stop manufacturing compounded versions of tirzepatide within the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said the transition period would give patients time to switch to the brand-name version.

It’s a blow to some compounding pharmacies, which say their copied drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its high price of about $1,000 per month. Zepbound and other weight loss drugs aren’t covered by many insurance plans, but Mounjaro, Eli Lilly’s diabetes counterpart, is.

It’s the latest in a high-stakes 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 meet unprecedented demand.

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

Following the lawsuit, the FDA said it would reevaluate removing tirzepatide from the shortage list. This allowed compound pharmacies to continue copycats while the agency reviewed its decision.

Compounded medications are tailored alternatives to brand-name medications, designed to meet a patient’s specific needs. When a brand-name drug is in shortage, compounding pharmacies may prepare 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 approved brand-name GLP-1 medications when they are available.

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

Patients have turned to compounded versions of tirzepatide because of intermittent shortages in the United States of the brand-name drug, which carries a high price tag of $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 experienced intermittent shortages over the past two years. But the FDA said earlier this month that all doses of those drugs were now available.

The agency has not yet announced whether it is removing semaglutide from its shortage list — a move that would likely affect even more compounding pharmacies because it is more widely used than tirzepatide.

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 combat illicit versions of their treatments, suing weight-loss clinics, medical spas and compounding pharmacies across the United States over the past year . Last month, the FDA also said it had received reports of overdoses of the compound semaglutide due to dosing errors, such as patients self-administering incorrect amounts of a treatment.