Generic Semaglutide to Become Available

Semaglutide is the active ingredient in popular brand-name medications like Ozempic and Wegovy, manufactured by the Danish pharmaceutical company Novo Nordisk. These drugs have seen a surge in demand for treating type 2 diabetes and for weight management. The primary patents for semaglutide in the United States are not expected to expire until 2031 or 2032, meaning a true, FDA-approved generic version is not anticipated to be available until then. Novo Nordisk holds numerous patents covering the compound and its applications. Some companies in the U.S. have been offering "compounded" versions of semaglutide. These are custom-made preparations by pharmacies and are not FDA-approved generics. This practice was permissible under federal law while the FDA had declared a drug shortage for semaglutide. As of early 2025, the FDA declared the semaglutide shortage to be resolved, which makes the widespread sale of compounded copies illegal under most circumstances. The FDA has raised concerns about the safety and efficacy of these unapproved compounded drugs, noting issues with different active ingredients (salt forms) and the potential for dosing errors. In response to the proliferation of these unauthorized versions, Novo Nordisk has filed over 130 lawsuits against compounding pharmacies, telehealth companies, and medical spas to halt the sale of what it terms "knockoff" products. Courts have issued numerous injunctions to stop these sales. While U.S. patients will have to wait for a true generic, other parts of the world will see them much sooner. Key patents for semaglutide are set to expire in countries like India, China, and Brazil in 2026. This has prompted a number of pharmaceutical companies in these regions to prepare for the launch of their own generic versions.