Eli Lilly’s weight-loss drugs no longer in shortage, FDA says
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The shortage of Eli Lilly and Co.’s blockbuster weight-loss and diabetes drugs is over, the U.S. Food and Drug Administration announced Wednesday.
Indianapolis-based Eli Lilly’s supply of Mounjaro, which is used to treat Type 2 diabetes, and popular weight-loss drug Zepbound, can now meet present and projected national demand, the FDA said in a statement.
Both medications, which trigger the hormone GLP-1 and curb hunger, use tirzepatide as their active ingredient. Mounjaro has been in shortage since shortly after its introduction in 2022. Zepbound also has been in short supply since being approved less than a year ago as demand for weight-loss drugs has skyrocketed.
The FDA’s shortage designation had let compounding pharmacies, which typically custom-make medications to suit individual patient needs, make copies of the wildly popular treatments. That business has boomed over the past two years. An end to the shortage designation, which Eli Lilly and other brand drugmakers sought, is a blow to those pharmacies and their business.
Sales of the two drugs totaled $4.3 billion in the second quarter, accounting for nearly 40% of Lilly’s revenue during the period.
Lilly has been making the case since August that its tirzepatide-based drugs are now “commercially available,” which the FDA agreed on. But the agency has warned that patients and prescribers might still experience “localized supply disruptions” as the products make their way to pharmacies.
Lilly has “invested significantly” to expand manufacturing for its weight-loss and diabetes drugs and bring new options to the market, executive vice president Patrik Jonsson said in a statement. The shortage’s end reflects the company’s “commitment to providing a steady stream of genuine and safe medicines,” he added.
The company reiterated the FDA’s warning that patients might still face challenges finding dosages of the medications. “The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock,” it said in a separate statement.
Eli Lilly and its rival Novo Nordisk, which makes the diabetes drug Ozempic and its weight-loss version Wegovy, have been in a fierce battle against the emerging industry making copies of their drugs. Lawyers representing Eli Lilly in August issued letters warning prescribers of the off-brand drugs to immediately halt doing so, The Washington Post reported.
For its part, the FDA has consistently warned that the off-brand weight-loss drugs aren’t as safe as the medications that it exhaustively reviews ahead of approval. The copies are inspected by states and the FDA, but the federal agency doesn’t approve such medications. There is no FDA-approved generic version for tirzepatide, the active ingredient in Mounjaro and Zepbound, or semaglutide, the active ingredient in Ozempic and Wegovy.
The immediate impact of the FDA’s action isn’t yet clear. Many patients still report difficulty getting the drug despite Lilly saying there’s enough.
Pharmacies that make copies of the weight-loss and diabetes drugs have been able to offer them for a couple of hundred dollars a month, while Eli Lilly and Novo Nordisk have shelled out billions of dollars to grow their supplies and meet regulatory standards.
Some compounding pharmacies have said that their tirzepatide-based drugs aren’t simply copies of Eli Lilly’s drugs because they include additional ingredients or are made in different dosage strengths. They cite those differences to argue they’ll be able to continue to legally produce them. They have also said their treatments are the primary reason the millions of patients who rely on the drugs have not seen a lapse in treatment during the shortage.
Scott Brunner, CEO of the trade group Alliance for Pharmacy Compounding, said the FDA’s announcement could be disruptive to patients who have come to depend on taking compounded tirzepatide. “They are being cut off cold-turkey, their prescription no longer fillable,” he said in a statement. The group said that pharmacies “must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound.”
The ability of pharmacies to make their own versions of Ozempic and Wegovy is unaffected, as the FDA still considers semaglutide, the active ingredient in both drugs, to be in shortage.