Sandoz wins FDA review for 2 generic tirzepatide GLP-1s

The FDA accepted Sandoz's applications for 2 generic versions of Eli Lilly's blockbuster obesity drugs Mounjaro and Zepbound.

"Sandoz could have one of the first generic versions of tirzepatide available in the US once the medicine goes off patent," the Swiss generic-drug maker said Monday.

The products, developed in-house, target tirzepatide, the active ingredient in both Mounjaro and Zepbound. Lilly has about a decade of patent protection left on those drugs, which generated roughly half of the company's revenue last year.

Generic competition threatens to erode pricing power in the multi-billion dollar GLP-1 market, where Mounjaro overtook Merck's Keytruda as the world's top-selling drug. Sandoz said it is building a pipeline of GLP-1s across key global markets combining internal capabilities and external partnerships.

Sandoz's acceptance for review comes as at least 120 companies globally develop hundreds of GLP-1 drugs, according to Bloomberg Intelligence. Novo Nordisk, Lilly's chief rival, faces generic versions of its own drugs already available in countries including India and Canada.

Lilly's Zepbound is the world's most popular obesity medicine, with the company shipping 7 injections every second, according to CEO Dave Ricks. The company also introduced Foundayo, a daily oral GLP-1 pill, in April.

The FDA review puts Sandoz on track to become one of the first generic tirzepatide suppliers, potentially reshaping competitive dynamics in the $100 billion-plus GLP-1 market. Investors will watch for the FDA's decision, which could come within months depending on the review timeline.

This article is for informational purposes only and does not constitute investment advice.