Semaglutide Patent Expires in Brazil, Opening Door to Lower-Cost Rivals

Overview

• Brazil’s patent on semaglutide expired on March 20 after Novo Nordisk failed in court to extend protection, ending roughly 20 years of exclusivity.
• Anvisa says about 15 filings are under review and none approved; EMS and Ávita Care are in a compliance phase after early-March queries and could reach pharmacies by June if their responses satisfy regulators.
• Competition is expected to pressure prices over time, with entrants likely to be biosimilars or synthetic peptide analogs rather than true generics, a shift that could reopen SUS cost-effectiveness debates after a prior R$8 billion budget impact stalled adoption.
• Indian manufacturers are preparing low-cost semaglutide injections, with reporting of potential near-term launches that could broaden access in middle-income markets.
• A large observational study in The Lancet Psychiatry linked semaglutide use to fewer psychiatric hospitalizations and lower depression and anxiety symptoms, though researchers emphasize the findings do not establish causality.