The U.S. Food and Drug Administration (FDA) announced on Wednesday that Eli Lilly’s prominent weight-loss medication is no longer facing shortages in the United States. According to the FDA’s website, the availability issues surrounding all doses of tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight management, have been addressed.
Despite this announcement, the FDA cautioned that patients and healthcare providers may still encounter sporadic local shortages as the products transition through the supply chain. A representative from Eli Lilly did not respond immediately to a request for comment from Reuters.
Mounjaro has been listed on the FDA’s shortage registry since late 2022, while Zepbound was added to the list in April of this year. To enhance accessibility, Lilly began selling vials of the lowest starter dose of Zepbound directly to consumers via its website.
The rising demand for both Mounjaro and Zepbound has prompted Eli Lilly to invest significantly in expanding production capabilities. Novo Nordisk, a Danish pharmaceutical company that produces competing drugs Ozempic and Wegovy, is also working to increase supply to meet the soaring demand.
Before declaring a shortage resolved, the FDA conducts an evaluation of the market and ensures that all backorders for the drug have been fulfilled. The agency confirmed with Eli Lilly that current supply and manufacturing capabilities are sufficient to meet both current and anticipated national demand for the medication.
Initially developed for diabetes management, GLP-1 therapies have demonstrated the potential to facilitate weight loss of up to 20% in clinical trials. Analysts project that the market for these treatments could reach approximately $150 billion in revenue by the early 2030s.
Both Eli Lilly and Novo Nordisk are actively expanding production at their existing facilities, constructing or acquiring new manufacturing sites, and pursuing partnerships with contract drug manufacturers to enhance supply.
Earlier today, Eli Lilly announced a $4.5 billion investment to establish a new facility in Indiana, aimed at innovating drug manufacturing processes and increasing the production of experimental medicines for clinical trials.
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