Lilly’s first-in-class medicine that activates both the GLP-1 and GIP receptors, Mounjaro, is the latest to be included on the FDA’s drug shortages list because of high demand.
Lilly’s Mounjaro (tirzepatide) is the latest to be included in FDA’s Drug Shortages database. Mounjaro, approved earlier this year to treat type 2 diabetes, is in short supply due to increased demand, according to the FDA and Lilly.
This follows supply problems with other popular diabetes medications, including Wegovy (semaglutide) and Ozempic (semaglutide), and Trulicity (dulaglutide). Novo Nordisk’s Wegovy was the first diabetes medication approved for chronic weight management in June 2021. While Novo Nordisk’s Ozempic and Lilly’s Trulicity are not approved by the FDA for weight loss, clinical trials have shown weight loss benefits in both medications, boosting demand for the diabetes medications.
“The strong global demand for Trulicity and U.S. demand for Mounjaro, amplified by global competitor incretin shortages, is resulting in potential short-term delayed fulfillments of wholesaler orders of some doses of Mounjaro and Trulicity,” a Lilly spokesperson told Formulary Watch.
Pharmacies may experience delays in receiving full shipments of Mounjaro through January 2023, the FDA’s drug shortages site said.
Lilly will continue to ship and distribute the product, but depending on “continued demand and competitor supply shortages, pharmacies and wholesalers may experience intermittent delays and outages of Trulicity 3.0/4.5 mg and Mounjaro 5.0 mg,” the spokesperson added.
Lilly is “continuing to monitor the strong demand, competitor supply challenges, as well as learn and project demand across Mounjaro and Trulicity doses,” the spokesperson said. "The situation is fluid and multi-factored, making it difficult to specify timing, but we remain committed to ensuring people with type 2 diabetes receive our medicines.”
Meanwhile, Trulicity, Wegovy and Ozempic are also included on the FDA’s Drug Shortages list. While the 1 mg and 2 mg doses of Ozempic are available for patients across the United States, Novo Nordisk is experiencing intermittent supply disruptions on the Ozempic pen that delivers 0.25 mg and 0.5 mg doses, “due to the combination of incredible demand coupled with overall global supply constraints,” Natalia Salomao Abrahao, senior director of corporate communications & media relations at Novo Nordisk, told Formulary Watch.
“While product continues to be manufactured and shipped, patients in some areas of the country will experience delays with these doses,” Salomao Abrahao said.
The supply problems are driven by higher-than-expected demand along with temporary capacity limitations at some of Novo Nordisk’s manufacturing sites, Salomao Abrahao said.
“Keeping our patients’ needs first, our global manufacturing facilities are now operating 24 hours, seven days a week, and we are investing to expand capacity. We are committed to minimize the impact on patients,” Salomao Abrahao added.
Novo Nordisk is on track to make all dose strengths of Wegovy available in December and a broad commercial re-launch will begin next year, according to Salomao Abrahao.
After Wegovy is available this month, it will then take a few weeks for product to be broadly available at retail pharmacies across the country, Novo Nordisk said on its website. The pharma maker is also making plans for additional production capacity to come online in 2023.
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