Generic Semaglutide availability announced

Semaglutide is the active ingredient in Novo Nordisk's popular drugs, Ozempic and Wegovy. While both are weekly injections, the FDA approved Ozempic to treat type 2 diabetes and Wegovy, which contains a higher dose, for chronic weight management. In the United States, the list price for a one-month supply of these medications can range from approximately $936 to $1,349 without insurance. This high cost has made access difficult for many, even as off-label use for weight loss has surged. While U.S. patents on semaglutide are not expected to expire until at least 2031, the situation is different abroad. Key patents are set to expire in major markets like China, India, Brazil, and Canada as early as 2026, opening the door for generic competition much sooner. A host of pharmaceutical companies are preparing to launch their own versions. In India, at least 10 firms, including Dr. Reddy's Laboratories, Cipla, and Sun Pharma, are getting ready to manufacture generic semaglutide. Similarly, at least 15 companies in China are developing generics, with several in the final stages of clinical trials. The introduction of generics is expected to trigger significant price drops. Analysts predict the cost of treatment in India could fall by as much as 90%, drastically increasing access to the medication in a country with a high prevalence of diabetes. To gain FDA approval in the U.S., a generic drug must be proven to have the same active ingredient, strength, and dosage form and to work in the same way in the body as the brand-name version. The versions currently sold by compounding pharmacies in the U.S. are not FDA-approved generics, but are permitted under specific circumstances like drug shortages.