Semaglutide Patent Expiry Opens a New Phase of Competition in Brazil’s Pharmaceutical Market
The expiry of the semaglutide patent in Brazil on March 20, 2026, opened the door to a new phase of competition in the market for medicines used to treat type 2 diabetes and manage weight. Months later, the effects are beginning to emerge, with new versions of the active ingredient entering the market and domestic and international pharmaceutical companies pursuing commercial opportunities.
According to a report published by EXAME on October 23, only two of the new synthetic versions identified in its survey were already available in Brazilian pharmacies: Ozivy, from EMS, and Semavy, from Hypera Pharma. Other companies were still awaiting regulatory or commercial steps before launching their products.
The developments illustrate how patent expiry can change competitive conditions without removing the other requirements involved in bringing a pharmaceutical product to market.
What changed when the patent expired?
In January 2026, Brazil’s Superior Court of Justice (STJ) Fourth Panel ruled against extending the patent terms for Ozempic and Rybelsus, both owned by Novo Nordisk. The decision followed the legal understanding that delays in administrative patent examination do not justify judicial extensions beyond the term established under Brazilian law.
The semaglutide patent subsequently expired on March 20, 2026, allowing other companies to develop medicines containing the same active ingredient, subject to the applicable regulatory requirements.
This marked a competitive turning point for Brazil’s pharmaceutical industry. Companies that had previously faced patent exclusivity as a barrier to entry gained new opportunities to develop and commercialize products.
However, patent expiry does not automatically authorize a medicine for manufacture and sale. Commercialization remains subject to health regulations, including demonstrating quality, safety, and efficacy to Brazilian Health Regulatory Agency (Anvisa).
Which companies are competing in this market?
The market’s opening has attracted manufacturers with different development, production, and distribution capabilities. Companies identified in EXAME’s report include EMS, Hypera Pharma, Ávita Care, Sun Pharmaceutical, Brainfarma, Ranbaxy and Germed.
Products are progressing through different regulatory and commercial stages. As of October 2026, Ozivy, from EMS, and Semavy, from Hypera Pharma, were the two new synthetic versions identified in the report as commercially available.
Other products, including Owozy, Seemasun, Zempneo, Orsema and Semaclique, had received regulatory approval but were not yet available in pharmacies, according to the report. The survey also identified a registration for a generic version of synthetic semaglutide from EMS.
The distinction between regulatory approval and commercial availability shows that entering a pharmaceutical market requires more than product development. Manufacturing capacity, distribution arrangements, commercial positioning, and compliance with applicable requirements can all affect launch timelines.
Why does patent expiry not end the intellectual property protection?
The expiry of a patent ends the exclusivity granted by that particular right, within the scope of its subject matter and term. It does not, by itself, mean that every technology associated with a medicine is free from intellectual property protection.
Depending on the circumstances, formulations, manufacturing processes, delivery devices and other technical solutions may be covered by separate rights, provided they meet the applicable legal requirements and are protected by valid titles.
Companies assessing market-entry opportunities must therefore consider the full set of potentially relevant rights rather than relying solely on the expiry date of the patent associated with an active ingredient.
In the pharmaceutical sector, this assessment can influence research and development decisions, licensing agreements, industrial partnerships and launch strategies. Identifying opportunities also requires careful examination of patent claims and the legal status of relevant rights.
Regulatory approval and commercial strategy are separate stages
The development of new semaglutide products also illustrates the difference between the ability to develop a product after patent exclusivity ends and the authorization to market it.
In March 2026, Anvisa reported that applications for medicines containing the same active ingredient were at different stages of review. The agency emphasized that patent expiry did not remove the requirement to demonstrate quality, safety, and efficacy.
The agency granted additional registrations in the following months. Nevertheless, regulatory approval did not mean that every product would immediately become available in pharmacies.
For pharmaceutical companies, this calls for integrated planning. Patent analysis must be considered alongside technological development, manufacturing capacity, regulatory processes, and commercial strategy.
It is also important to distinguish between a medicine’s approved indications. Authorization for one therapeutic purpose does not automatically permit marketing for another; the approved indications must be verified for each product.
What does this mean for the pharmaceutical industry?
The semaglutide case illustrates how changes in patent protection can reshape competition in a commercially significant market.
For manufacturers seeking to enter the sector, the end of exclusivity may create opportunities for product development and expansion. Companies already operating in the market may need to adjust their portfolios, differentiation, distribution, and competitive positioning.
The shift also highlights the importance of monitoring court decisions, patent terms and regulatory proceedings in a coordinated manner. An opportunity identified through intellectual property analysis must be assessed against the technical, legal and commercial conditions required to bring it to market.
Brazil’s semaglutide market therefore demonstrates that patent expiry is an important milestone, but not the end of strategic analysis. Assessing the protection landscape, understanding regulatory requirements, and planning market entry can be decisive for pharmaceutical companies competing in this segment.










