Sandoz Submits Generic Tirzepatide Applications to FDA
Sandoz AG announced that it has submitted two generic versions of tirzepatide to the U.S. Food and Drug Administration for review. The applications target treatment of type‑2 diabetes and weight‑management, mirroring the indications of Eli Lilly’s branded products Mounjaro and Zepbound. Eli Lilly’s tirzepatide patent in the United States is scheduled to expire in 2036, after which generic competition may enter the market.
The FDA’s standard review timeline for standard drug applications permits up to ten months to evaluate safety, though the agency has not provided a specific decision date for Sandoz’s submissions.
In November, Sandoz had indicated plans to launch unbranded versions of Novo Nordisk’s diabetes drug Ozempic in Canada by the end of June; the company has not issued an update on that launch.
The filing reflects broader industry interest in the GLP‑1 weight‑loss drug segment, as multiple pharmaceutical firms seek to capture growing demand for obesity treatments.