Eli Lilly's weight-loss drug Zepbound is no longer available

The Food and Drug Administration said Thursday that the active ingredient in… Eli Lilly There is no longer a shortage of the weight loss drug Zepbound, a decision that will ultimately prevent compounding pharmacies from making cheaper, generic versions of the injection.

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

The agency's decision, based on a comprehensive analysis, marks the end of a period in which some pharmacies could make, dispense or dispense unapproved versions of tirzepatide — the active ingredient in Zepbound — without facing repercussions for drug shortage violations.

Compounding pharmacies should stop making 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 will give patients time to switch to the branded version.

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

It's the latest in a high-stakes dispute between compounding pharmacies and the Food and Drug Administration over shortages of tirzepatide, the active ingredient in both Zepbound and Mounjaro. Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep up with unprecedented demand.

A trade organization representing compounding pharmacies — the Association for Outsourcing Facilities — filed a lawsuit against the FDA on October 8 over the agency's decision to remove tirzepatide from the official drug shortage list just days earlier. The group claims the FDA acted without proper notice, ignoring evidence that a shortage of tirizipatide still exists. It also claimed that the FDA's action was a coup for Eli Lilly that came at the expense of patients.

After the lawsuit, the FDA said it would reevaluate removing trizipatide from the deficiency list. That allowed compounding pharmacies to continue making copycats while the agency reviewed its decision.

Compounded medications are customized alternatives to brand-name medications designed to meet the needs of a specific patient. When there is a shortage of a brand-name drug, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.

The FDA does not review the safety and effectiveness of combination products, and the agency has urged consumers to take approved GLP-1 branded medications when they are available.

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

Patients have turned to combination versions of tirizpatide amid intermittent U.S. shortages of the brand-name drugs, which carry hefty prices of up to $1,000 a month before insurance and other rebates. Many health plans do not cover the weight-loss drug terzepatide, making combination versions a less expensive alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. But the Food and Drug Administration said earlier this month that all doses of these drugs are now available.

The agency has not yet announced whether it will remove semaglutide from its deficiency list — a decision that will likely affect compounding pharmacies more because it is more widely used than tirezpatide.

Wegovy, Ozempic, Zepbound, and Mounjaro are under patent protection in the United States and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their medicines to third-party groups. The companies say this raises questions about what some manufacturers are selling and marketing to consumers.

Both Novo Nordisk and Eli Lilly have stepped in to address illicit versions of their treatments, filing suit against weight-loss clinics, medical spas and compounding pharmacies across the United States over the past year. The FDA also said last month that it had received reports of patients taking overdoses of the combination semaglutide due to dosing errors such as patients self-administering incorrect amounts of the medication.