Ozempic, Wegovy & Rybelsus: Patente Expira no Brasil – Preços de Genéricos e Acesso ao SUS?

Brazil Braces for Lower Prices as Ozempic Patent Expires, Opening Door to Generic Competition

The patent for semaglutide, the active ingredient in popular medications like Ozempic, Wegovy, and Rybelsus, expired in Brazil this Friday, March 20th, 2026. This pivotal moment is expected to unlock the market to generic and biosimilar versions of the drug, potentially offering significant cost relief to patients managing diabetes, and obesity. The expiration marks the end of two decades of exclusive rights held by Novo Nordisk, the Danish pharmaceutical company that developed semaglutide. The move is anticipated to increase access to these medications, which have gained prominence not only for their therapeutic benefits but also, controversially, for off-label apply in weight loss.

For years, Ozempic and its related drugs have been prescribed to treat type 2 diabetes by helping to regulate blood sugar levels. More recently, Wegovy, a higher-dose version of semaglutide, received approval for chronic weight management. The medications work by mimicking a natural hormone, glucagon-like peptide-1 (GLP-1), which helps to suppress appetite and increase insulin secretion. However, the high cost of these medications has been a significant barrier to access for many, prompting a search for more affordable alternatives. The Brazilian Health Regulatory Agency (Anvisa) will now oversee the approval process for these new entrants into the market, ensuring they meet the necessary safety and efficacy standards.

The Patent Landscape and the Rise of Generics

Pharmaceutical innovation is often protected by patents, granting the developing company exclusive rights to manufacture and sell a drug for a defined period – typically 20 years in Brazil, as stipulated by national legislation. According to Anvisa, this exclusivity is intended to incentivize research and development by allowing companies to recoup their investment. Novo Nordisk successfully defended its patent on semaglutide for two decades, but with its expiration, other pharmaceutical manufacturers are now eligible to produce and market generic versions, subject to Anvisa’s rigorous approval process. This process involves demonstrating bioequivalence – that the generic drug delivers the same therapeutic effect as the original.

The introduction of generic medications typically leads to increased competition and, lower prices. In Brazil, generic drugs are legally required to be at least 35% cheaper than their branded counterparts. However, a study conducted by researchers at the University of Brasília and the Federal University of Santa Catarina found that generics often cost 59% less than reference drugs, while similar drugs (those with slightly different inactive ingredients) are typically 15% cheaper. Anvisa has also taken steps to prevent the unregulated manipulation of semaglutide, prohibiting compounding pharmacies from producing their own versions of the drug to ensure patient safety and product quality.

Impact on the Brazilian Healthcare System and Potential for SUS Inclusion

The potential for lower prices has significant implications for Brazil’s public healthcare system, known as the Sistema Único de Saúde (SUS). In 2025, the National Commission for the Incorporation of Technologies in SUS (Conitec) initially rejected the inclusion of semaglutide and liraglutide (another GLP-1 receptor agonist) in the public health system, citing a projected budgetary impact exceeding 8 billion reais – nearly double the budget of the Farmácia Popular program in 2025. However, the anticipated price reductions resulting from generic competition could alter this calculation.

The Ministry of Health has already signaled its intention to prioritize the registration of generic semaglutide and liraglutide medications with Anvisa, specifically for the treatment of obesity and type 2 diabetes. In a statement, the Ministry indicated that the availability of more affordable generics, with an estimated price reduction of 30% on average, will be a key factor in reassessing the feasibility of incorporating these drugs into the SUS formulary. This could dramatically expand access to these medications for millions of Brazilians who currently cannot afford them.

Anvisa’s Role and the Approval Process

Anvisa plays a crucial role in ensuring the quality and safety of all medications marketed in Brazil. The agency is currently reviewing applications from several pharmaceutical companies, including EMS and Ávita Care, seeking approval to manufacture and sell generic versions of semaglutide. As reported by G1 Globo, Anvisa is expected to announce its decisions on these applications in the coming weeks. The agency may request additional information from the companies before granting final approval, ensuring that the generic medications meet the same rigorous standards as the original Ozempic.

The approval process for biosimilar medications – those that are highly similar to the original biologic drug – is particularly complex, requiring extensive data demonstrating comparability in terms of safety, efficacy, and quality. Anvisa’s thorough evaluation is essential to maintain public trust and ensure that patients receive effective and safe treatments.

Celebrity Use and Off-Label Prescriptions

The increasing popularity of semaglutide has been fueled, in part, by reports of its effectiveness for weight loss, even among individuals without diabetes. This has led to increased demand and, in some cases, off-label prescriptions – where a drug is used for a purpose other than what it was originally approved for. The use of Ozempic and Wegovy by celebrities has further amplified public awareness and demand, raising concerns about potential shortages and equitable access for those who genuinely need the medication for diabetes management.

While semaglutide can be effective for weight loss, It’s not a quick fix and should be used under the guidance of a healthcare professional. Potential side effects include nausea, vomiting, diarrhea, and, in rare cases, more serious complications. It’s crucial for patients to discuss the risks and benefits of semaglutide with their doctor before starting treatment.

Key Takeaways

• The patent for semaglutide, the active ingredient in Ozempic, Wegovy, and Rybelsus, expired in Brazil on March 20th, 2026.
• The expiration is expected to lead to increased competition and lower prices for these medications.
• Anvisa is currently reviewing applications for generic versions of semaglutide from several pharmaceutical companies.
• The potential for lower prices could pave the way for the inclusion of semaglutide in Brazil’s public healthcare system (SUS).
• Off-label use of semaglutide for weight loss has raised concerns about equitable access and potential shortages.

Looking ahead, the coming months will be critical as Anvisa reviews the applications for generic semaglutide and determines whether to incorporate these medications into the SUS. The decisions made by the agency will have a profound impact on the affordability and accessibility of these life-changing drugs for millions of Brazilians. We will continue to monitor developments and provide updates as they become available.

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