The FDA says Eli Lilly’s weight-loss drug Zipbound is no longer in short supply.

The Food and Drug Administration said Thursday that the active ingredients in of Eli Lilly Weight loss drug is Zepbound There is no shortage nowa decision that will eventually prevent compounding pharmacies from making unbranded versions of the injection.

The agency’s decision, based on a comprehensive analysis, marks the end of a period where some pharmacies compounded, dispensed or dispensed the active ingredient in the drug, tirzapatide, without facing consequences for violations related to treatment shortages. can do

The FDA said it will provide a 60- to 90-day transition period where it will not take action against pharmacies for making the compound tirzapatide, giving patients time to switch to the branded version.

The combination is the latest in a high-stakes dispute between pharmacies and the FDA over shortages of tirzapatide, the active ingredient in both Zipbound and Eli Lilly’s diabetes treatment Monjaro. Eli Lilly has. Billions invested. to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand.

A trade organization representing compounding pharmacies—the Outsourcing Facilities Association— The case The FDA on Oct. 8 responded to the agency’s decision to remove tericeptide from its official drug shortage list days earlier. The group alleges that the FDA acted without adequate notice, ignoring evidence that a tarzeptide shortage still exists. He also argued 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 reconsider removing terceptide from the shortage list. It allowed compounding pharmacies to continue making copycats while the agency reviewed its decision.

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

The US Food and Drug Administration does not evaluate the safety and efficacy of compounded products, and the agency does not Emphasis on users To take approved, branded GLP-1 drugs when they are available.

However, the FDA inspects some outsourcing facilities that, according to it, compound drugs. Website.

Amid intermittent shortages of the branded drug in the U.S., patients have turned to compounded versions of terceptide, which cost a hefty $1,000 a month before insurance and other rebates. Many health plans do not cover tirezapeptide for weight loss, making the compound version a more affordable alternative.

Semaglutide, the active ingredient in Vigovi and Ozempic, has been in intermittent shortage for the past two years. But earlier this month, the FDA said all doses of these drugs are now available.

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

Vigovi, Ozempic, Zipbound and Monjaro are under patent protection in the US and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their drugs to outside groups. Companies say Raises questions About what some manufacturers are selling and marketing to consumers.

Both Novo Nordisk and Eli Lilly have taken steps to address illegal versions of their treatments. The case Weight loss clinics, medical spas and compounding pharmacies across the US over the past year. The FDA also said last month that it Reports received Compounded semaglutide overdose due to patient dosing errors such as patients self-administering the wrong amount of treatment.