Cheaper versions of two of the most widely used weight-loss and diabetes drugs in the United States are now formally under federal review. The Food and Drug Administration has agreed to review applications from Swiss pharmaceutical company Sandoz to produce generic versions of Mounjaro and Zepbound, both of which contain the active ingredient tirzepatide.
The brand-name drugs are manufactured by Eli Lilly, according to a report by Healthline. Mounjaro is approved to treat type 2 diabetes. Zepbound is approved for obesity and sleep apnea. Both are taken as weekly injections and are meant to be used alongside a healthy diet and regular exercise.
Without insurance, Mounjaro and Zepbound can cost more than $1,000 per month. Sandoz estimates its generic versions would run between $200 and $400 per month for patients without coverage. Generic medications are generally less expensive than brand-name drugs because manufacturers do not carry the original research and development costs.
Sandoz has requested approval for the same uses as the existing brand-name medications. The FDA has not specified how long the review process will take.
"Sandoz is building its GLP-1 development platform, and this submission reflects true in-house innovation," said Claire D'Abreu-Hayling, the president of Generics Development and the chief scientific officer at Sandoz, in a press statement. "It represents a key first step in our efforts to bring this medicine to market and underscores our ambition to increase competition and expand affordability in a critical area of healthcare need."
There is a significant legal obstacle, however. Eli Lilly holds patent protection on Mounjaro and Zepbound in the United States until 2036. That protection limits when a generic version could actually reach American patients, even if the FDA grants approval.
Patents are expiring in other countries, and competition in those markets is already building. In June, Canadian health officials approved a generic version of Novo Nordisk's Wegovy, a weekly semaglutide injection used for weight loss. That generic, called Sevian, is manufactured by Canadian company Apotex. Canadian officials said they are also reviewing additional applications.
In the United States, compounded versions of tirzepatide were briefly allowed on the market after the FDA declared a shortage of GLP-1 medications in December 2022. The FDA has since moved to end those allowances as the shortage has eased. The Sandoz applications represent the first formal attempt to bring a true generic tirzepatide to the American market through the standard regulatory process.
The race to enter the GLP-1 market reflects strong demand. These medications have reshaped treatment for obesity and type 2 diabetes, and access has remained limited for many patients due to cost and insurance coverage gaps.