FDA Reviews Sandoz's Generic Tirzepatide Applications

The U.S. Food and Drug Administration (FDA) has accepted for review two generic versions of tirzepatide developed by Swiss pharmaceutical company Sandoz.

This development is expected to enhance competition in the rapidly expanding obesity and diabetes treatment market, as the approved medication will directly compete with Eli Lilly's blockbuster tirzepatide brand, Mounjaro, and Zepbound, which are used to treat type 2 diabetes and support weight management. Sandoz's proposed generic product aims to provide patients with additional treatment options once it reaches the market.

The FDA has not indicated when it will complete its review but states on its website that the standard review timeline for drug applications is within 10 months of submission. The competition in the GLP-1 market is anticipated to intensify as drug manufacturers position themselves ahead of the expiration of Eli Lilly's U.S. patent for tirzepatide in 2036.

Additionally, Sandoz is pursuing opportunities in the diabetes drug market and announced plans to launch an unbranded version of Novo Nordisk's Ozempic in Canada by the end of June.