Sandoz submits generic obesity drug applications to FDA
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Investing.com -- Sandoz has submitted two generic versions of tirzepatide to the U.S. Food and Drug Administration for review. The drugs would compete with Eli Lilly's obesity and diabetes treatments Mounjaro and Zepbound if approved.
The Swiss generics drugmaker said the proposed medications would treat type-2 diabetes and weight management, matching the same conditions as Eli Lilly's branded products. Eli Lilly's tirzepatide patent expires in 2036 in the United States.
"Sandoz tirzepatide could be one of the first generic tirzepatide products available for patients in the U.S. on market formation," the company said in a statement.
The FDA has not indicated how long its review process will take. The agency's standard timeline allows up to 10 months to decide on the safety of standard drug applications after submission.
Sandoz announced in November that it planned to launch unbranded versions of Novo Nordisk's diabetes drug Ozempic in Canada by the end of June. The company has not provided an update on that launch.
Multiple pharmaceutical companies are seeking to enter the weight loss drug market as demand for GLP-1 medications continues to grow.
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