On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version of Novo Nordisk’s Ozempic®, for type 2 diabetes. Sandoz is expecting to launch the product in the second half of 2026.
Owozy® was developed by Malta-headquartered Adalvo and will be commercialised in Brazil by Sandoz in a pre-filled, multi-dose disposable pen. The Brazilian market for GLP-1 is estimated to be worth USD 1.8 billion, with more than 16.5 million Brazilians living with diabetes.
The Brazilian approval comes just weeks after Sun Pharma’s generic semaglutide injection was approved in South Africa (announced 15 July 2026), with launch following shortly thereafter. A number of generic semaglutide products have also launched in India and Canada. In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide. Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.
Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents. Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026. Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.