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29th Jun, 2026 12:00 AM
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FDA Set to Review Sandoz's Generic GLP-1s

ZURICH, June 29 (Reuters) - The U.S. Food and Drug Administration has agreed to review ⁠Swiss generics drugmaker Sandoz's two generic tirzepatide GLP-1s that, if approved, would rival ⁠obesity drugs made by Eli Lilly.

With Eli Lilly's tirzepatide patent running ⁠out in 2036 in ‌the U.S., makers of alternative drugs are fighting for a share of the weight loss market.

• Sandoz says its drugs would treat the same conditions, including type-2 diabetes as ‌well as weight management, as Eli Lilly's Mounjaro ​and Zepbound.

• "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.

• ⁠It is unclear how ​long the FDA review ‌will take.

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• Its website says it expects to decide on whether standard drugs are safe no more than 10 ​months after applications are received.

• Sandoz ‌said ‌in November it expected unbranded versions of Novo Nordisk's diabetes ‌drug Ozempic in ​Canada to be launched by the end of June, as it aims to be one of the ⁠first in the market, but has yet to ‌make any further announcement.

(Reporting by Marleen Kaesebier in Zurich; ​editing by Barbara Lewis)


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