Eli Lilly's weight loss drug Zepbound is no longer in shortage, according to the FDA.

• The Food and Drug Administration has announced that the active ingredient in Eli Lilly's weight loss drug Zepbound is no longer in shortage, which means that compounding pharmacies will no longer be able to produce unbranded versions of the injection.
• The FDA has announced a 60 to 90-day transition period during which it will not penalize pharmacies for selling compounded tirzepatide, allowing patients to gradually switch to the branded version.
• The ongoing conflict between compounding pharmacies and the FDA centers on the shortage of tirzepatide, the active component in Eli Lilly's popular weight loss drug Zepbound and diabetes treatment Mounjaro.

The Food and Drug Administration (FDA) announced on Thursday that the active ingredient in weight loss drug Zepbound is no longer in shortage, which means that compounding pharmacies will no longer be able to produce cheaper, unbranded versions of the injection.

"The FDA has resolved the shortage of tirzepatide injection products, which started in December 2022, and is continuing to monitor supply and demand for these products."

The agency's decision, following a thorough examination, signifies the conclusion of a time when specific pharmacies could produce, distribute, or sell unauthorized versions of tirzepatide – the active component in Zepbound – without facing any consequences for violations related to the drug's scarcity status.

The FDA has mandated that compounding pharmacies cease production of compounded tirzepatide within the next 60 to 90 days, based on the type of facility. The agency has stated that this transition period will allow patients to switch to the branded version.

Some compounding pharmacies are facing a blow as they say their copycat drugs help patients who lack insurance coverage for Zepbound and can't afford its high price of around $1,000 a month. However, Eli Lilly's diabetes medication Mounjaro is covered by many insurance plans.

Eli Lilly is facing a high-stakes dispute with compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Eli Lilly's diabetes treatment Mounjaro. Despite investing billions to expand its manufacturing capacity for tirzepatide, Eli Lilly is struggling to keep up with the unprecedented demand.

The Outsourcing Facilities Association, a trade organization representing compounding pharmacies, filed a lawsuit against the FDA on October 8th, challenging the agency's decision to remove tirzepatide from its official drug shortages list. The group claims that the FDA acted without proper notice and disregarded evidence indicating that a shortage of tirzepatide still exists. Additionally, the association argued that the FDA's action was a favor to Eli Lilly at the expense of patients.

The FDA announced that it would reassess its decision to remove tirzepatide from the shortages list, allowing compounding pharmacies to continue producing copies of the drug during the review process.

Custom-made alternatives to branded drugs, known as compounded medications, are designed to meet specific patient needs. Under federal law, compounding pharmacies can prepare copies of brand-name medications when they are in shortage.

The FDA does not assess the safety and effectiveness of compounded products and advises consumers to opt for approved, branded GLP-1 medications when possible.

According to the FDA's website, the agency does inspect some outsourcing facilities that compound drugs.

Amid U.S. shortages of branded tirzepatide, patients have turned to compounded versions of the drug, which are more affordable due to their lower price tags of $1,000 per month before insurance and other rebates. Many health plans don't cover tirzepatide for weight loss, making compounded versions a more affordable alternative.

Semaglutide, the active ingredient in Wegovy and Ozempic, has been experiencing intermittent shortages for the past two years. However, the FDA recently announced that all doses of these drugs are now available.

The agency has not yet decided whether to remove semaglutide from its shortage list, which could impact a larger number of compounding pharmacies as it is more widely used than tirzepatide.

The drugs Wegovy, Ozempic, Zepbound, and Mounjaro are protected by patents in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not provide the active ingredients in their drugs to outside groups. This raises questions about what some manufacturers are selling and marketing to consumers.

Both Novo Nordisk and Eli Lilly have taken legal action against unauthorized versions of their weight loss treatments by suing clinics, medical spas, and compounding pharmacies across the U.S. over the past year. The FDA recently announced that it has received reports of patients overdosing on compounded semaglutide due to dosing errors, such as patients self-administering incorrect amounts of the treatment.