The expiration of semaglutide patent protection in Brazil has triggered a new phase of competition in the market for medicines used to treat diabetes and manage weight. Following the end of the protection period, Brazil’s Health Regulator Agency, Anvisa, began approving a new generation of semaglutide-based products, including synthetic versions and the first generic in the category.
According to VEJA, 12 semaglutide-based medicines have now been authorized by Brazil’s Health Regulator Agency (Anvisa), with some already available and others still awaiting pricing and commercial launch.
Patent expiration opens the market to new competitors
Semaglutide became globally known through Ozempic, developed by Danish pharmaceutical company Novo Nordisk. With patent protection ending in Brazil, local manufacturers began competing for a share of a rapidly expanding market.
The first major development came in May 2026, when Anvisa approved Ozivy, manufactured by Brazilian pharmaceutical company EMS. The product contains synthetic semaglutide and reached Brazilian pharmacies in June, selling 200,000 units in July alone, according to the report.
In July, Anvisa also authorized five other similar medicines:
- Owozy
- Seemasun
- Zempneo
- Semavy
- Orsema
The agency subsequently approved two additional products, including the first generic version developed by EMS. Competition now involves different regulatory categories and development approaches.
Competition and potential price impact
The growing number of manufacturers is expected to increase competition and potentially put downward pressure on prices.
Ozivy, the first domestically produced semaglutide injection pen, entered pharmacies at USD 64 (R$ 333) per unit under EMS’s Vida + Leve program. The company attributes its competitive pricing to internally developed technology and fully local production.
Novo Nordisk, meanwhile, remains active in the Brazilian market. In late 2025, the company entered into an agreement with the Brazilian pharmaceutical company Eurofarma to produce and distribute semaglutide-based medicines.
The development demonstrates that patent expiration does not necessarily remove the original innovator from the market. Instead, it can fundamentally reshape competitive dynamics once exclusivity ends.
Innovation beyond replication
The arrival of new products also highlights the distinction between biological and synthetic medicines.
The semaglutide originally used in Ozempic and Wegovy is a biological medicine manufactured using cultured cells. Several of the products now authorized in Brazil, however, use semaglutide produced through chemical synthesis.
This distinction is relevant to both intellectual property and regulatory strategies, as patent expiration does not simply mean reproducing the original technology developed by the innovator.
In the case of Ozivy, for example, the use of a synthetic manufacturing route allowed the product to be classified as a new medicine, despite using the same underlying active substance. The generic version subsequently approved by Anvisa uses Ozivy as its reference product.
Regulatory oversight keeps pace with market expansion
The rapid increase in the number of available products has also prompted Anvisa to intensify its review of registration applications.
According to the report, the agency reviewed 24 applications, of which 11 had been completed at the time of publication: six were approved and five rejected. The regulatory process includes assessment of technical dossiers and inspections of manufacturing facilities.
The expansion is occurring alongside concerns over an illegal market for unregulated products. Between November 2025 and July 2026, 9.2 lb of semaglutide and 330 lb of tirzepatide in raw-material form were imported. During the same period, Anvisa conducted 33 inspections of compounding pharmacies, 14 of which were conducted jointly with the Federal Police.
Intellectual property and pharmaceutical market transformation
The semaglutide case illustrates how the expiration of patent exclusivity can rapidly reshape competition within a pharmaceutical market.
The arrival of new market participants may contribute to:
- Greater availability of medicines;
- Development of alternative manufacturing technologies;
- Potential price reductions;
- Increased competition among manufacturers;
- Broader access to treatments.
At the same time, the case demonstrates that patent expiration is only one step in the market-entry process. Regulatory approval, manufacturing capacity, pricing, and commercial strategies also determine how quickly competition reaches consumers.
