Is Semaglutide legal in Brazil?

Anvisa registered Ozempic (2018), Rybelsus (2020, tablets) and Wegovy (2023, weight management; liver indication added December 2025). Anvisa says the patent expired on 2026-03-20 but registration is still required. Ozivy (EMS, 2026-05-26) is a synthetic version classed as a new drug for type 2 diabetes, and the first generics (EMS, Germed) were registered in August 2026. Anvisa registered five more synthetic semaglutide products for type 2 diabetes on 2026-07-29. It is prescription-only with retention under RDC 973/2025. Since Despacho 97/2025, biotechnology-derived semaglutide may be imported for compounding only if it comes from the registered manufacturer. Anvisa said synthetic semaglutide could not be compounded until a synthetic medicine was registered, which first happened with Ozivy. Anvisa is revising the compounding rules.