The U.S. Food and Drug Administration (FDA) has accepted for review two generic versions of tirzepatide developed by Swiss pharmaceutical company Sandoz, a move that could pave the way for increased competition in the rapidly expanding obesity and diabetes treatment market.
If approved, the medicines would become direct competitors to Eli Lilly’s blockbuster tirzepatide brands, Mounjaro and Zepbound, which are used to treat type 2 diabetes and support weight management.
Sandoz said its proposed generic products are intended for the same medical conditions as Eli Lilly’s therapies, offering patients additional treatment options once they reach the market.
“Sandoz tirzepatide could be one of the first generic tirzepatide products available for patients in the U.S. upon market formation,” the company said.
The FDA has not indicated when it will complete its review, however, the agency states on its website that standard drug applications are generally reviewed within 10 months of submission.
Competition in the GLP-1 market is expected to intensify as drug manufacturers position themselves ahead of the expiration of Eli Lilly’s U.S. patent on tirzepatide in 2036.
Meanwhile, Sandoz is also pursuing opportunities in the diabetes drug market.
The company announced in November that it expected to launch unbranded versions of Novo Nordisk’s Ozempic in Canada by the end of June as part of its strategy to secure an early foothold in the market. However, it has yet to provide an update on the planned launch.
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