FDA says Eli Lilly’s weight loss drug Zepbound is no longer in shortage

The Food and Drug Administration on Thursday signified the active ingredient in Eli Lilly’s weight loss drug Zepbound is no longer in shortage, a decision that will finally bar compounding pharmacies from making cheaper, unbranded versions of the injection.

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

The agency’s decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could create, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations cognate to the treatment’s shortage status.

Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 light of days, depending on the type of facility, the agency said. The FDA said that transition period will give patients for the present to switch to the branded version.

It’s a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t experience insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight sacrifice drugs are not covered by many insurance plans, but Eli Lilly’s diabetes counterpart Mounjaro is.

It’s the latest in a high-stakes dispute between combine pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Mounjaro. Eli Lilly has invested billions to increase its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand.

A trade organization representing fuse pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its formal drug shortages list just days earlier. The group alleges the FDA acted without proper notice, wink ating evidence that a shortage of tirzepatide still exists. It also contended that the FDA’s action was a coup for Eli Lilly that secured at the expense of patients.

Following the suit, the FDA said it would reevaluate removing tirzepatide from the shortages list. That brooked compounding pharmacies to continue making copycats while the agency reviewed its decision.

Compounded medications are custom-made surrogates to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding druggists can prepare copies of the drug if they meet certain requirements under federal law.

The Food and Drug Administration does not inspect the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are elbow. 

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

Patients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs, which cause to die a continue hefty price tags of $1,000 per month before insurance and other rebates. Many health plans don’t front tirzepatide for weight loss, making compounded versions a more affordable alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in rhythmical shortages over the past two years. But the FDA earlier this month said all doses of those drugs are now available.

The force has yet to announce whether it is removing semaglutide from its shortage list — a decision that would likely affect despite that smooth more compounding pharmacies since it is more widely used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are eye patent protection in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their drugs to outside accumulations. The companies say that raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly experience both stepped in to address illicit versions of their treatments, suing weight loss clinics, medical spas and concocting pharmacies across the U.S. over the past year. The FDA last month also said it had received reports of patients overdosing on formulated semaglutide due to dosing errors such as patients self-administering incorrect amounts of a treatment.