An injection pen for Eli Lilly and Company’s weight loss drug Zepbound is on display in New York City on December 11, 2023.
Brendan McDermid | Reuters
The U.S. Food and Drug Administration said Thursday that the active ingredient Eli Lilly and Company Diet Pill Zepbound Is no more shortagea decision that will ultimately ban compounding pharmacies from producing cheaper, unbranded injectables.
“The FDA has determined that the product shortage of tezepatide injection that began in December 2022 has been resolved,” the agency said in a letter. “The FDA will continue to monitor the supply and demand for these products.”
The agency’s decision, based on a comprehensive analysis, marks the end of a period in which certain pharmacies could manufacture, distribute or dispense unapproved tilsiparatide, the active ingredient in Zepbound, without violating regulations related to treatment shortages and be affected.
The agency said compounding pharmacies must stop manufacturing compound tilsiparatide within the next 60 to 90 days, depending on the type of facility. The transition period will give patients time to switch to the branded version, the FDA said.
That’s a blow to some compounding pharmacies, which say their generic drugs can help patients who don’t have Zepbound insurance and can’t afford the hefty price of about $1,000 a month. Zepbound and other weight-loss drugs aren’t covered by many insurance plans, but Eli Lilly’s diabetes drug Mounjaro is.
This is the latest in a series of high-stakes disputes between compounding pharmacies and the FDA over a shortage of tilsiparatide. Tirsiparatide is the active ingredient in Zepbound and Eli Lilly and Company’s diabetes treatment Mounjaro. Eli Lilly and Company has Invest billions Expanding its tilsiparatide manufacturing capacity as the company struggles to keep up with unprecedented demand.
The Outsourcing Facilities Association, the trade group representing compounding pharmacies, sued The FDA launched an investigation on Oct. 8 into the agency’s decision days earlier to remove tilsiparatide from its official drug shortage list. The group claims the FDA took action without proper notification and ignored evidence that there was still a shortage of tezepatide. It also viewed the FDA’s action as a coup by Eli Lilly at the expense of patients.
After the lawsuit, the FDA said it would re-evaluate removing tsiparatide from the shortage list. This allows compounding pharmacies to continue making generic products while the agency reviews its decision.
Compounded drugs are customized alternatives to brand-name drugs designed to meet the needs of specific patients. When there is a shortage of a brand-name drug, compounding pharmacies can prepare copies of the drug if certain requirements under federal law are met.
The U.S. Food and Drug Administration does not review the safety and efficacy of combination products; the agency has urge consumers Take an approved brand name GLP-1 medicine (if available).
However, the FDA does inspect some outsourcing facilities that compound drugs, according to the FDA. website.
Because of intermittent shortages of brand-name tilsiparatide in the United States, patients are turning to combined versions of tilsiparatide, which cost up to $1,000 a month before insurance and other rebates. Many health plans do not cover tilsiparatide for weight loss, making the combined version a more affordable alternative.
Semaglutide, the active ingredient in Wegovy and Ozempic, has been in intermittent shortages for the past two years. But the FDA said earlier this month that all doses of the drugs are now available.
The agency has not yet announced whether it will remove semaglutide from its shortage list — a decision that could affect more compounding pharmacies because it is more widely used than tezepatide.
Wegovy, Ozempic, Zepbound and Mounjaro are protected by patents in the United States and abroad, and Novo Nordisk and Eli Lilly do not provide the active ingredients in their drugs to outside parties. These companies stated ask questions About the products some manufacturers sell and market to consumers.
Novo Nordisk and Eli Lilly have both stepped in to address illegal versions of their treatments, sue Over the past year, weight loss clinics, medical spas and compounding pharmacies across the United States. The FDA also stated last month that report received Patients who have overdosed on co-semaglutide due to a dosing error (e.g., the patient self-administered an incorrect dose of treatment).
