At this moment, two applications for registration of the substance used to manufacture the medicines are under analysis
With the fall of Ozempic’s patent in Brazil this Friday (20), two new medicines with the same purpose as pens for the treatment of diabetes and obesity can be approved by Juneaccording to the National Health Surveillance Agency (Anvisa).
The Danish company, Novo Nordisk, maker of Ozempic, reached the maximum period of 20 years of exclusivity provided for by Brazilian law for the creation of semaglutide. Now the substance can be produced and sold by third parties.
At this time, two applications for registration of synthetic semaglutide depend on the company data presentation so that the analysis can move forward. In both cases, the deadline for companies to respond is the end of June. In the area of biological semaglutide, one product is being analyzed and another is awaiting evaluation.
Anvisa reported that the analysis of the current processes for registering the substance had beginning in the second half of 2025, after publishing the notice that prioritized the evaluation of GLP-1 analogue products (semaglutide). Although the first request entered evaluation at the end of 2023, most requests only arrived in 2025.
According to Anvisa, “the evaluation of synthetic semaglutide analogues has been a technical challenge for regulatory agencies around the world”. Since to date, none of the world’s main medicine agencies, such as those in Japan, Europe and the USA, have registered synthetic analogues of the substance.
Currently there are 15 requests for analysis gives synthetic semaglutide:
- 5 are under analysis;
- 8 are awaiting the start of evaluations;
- 2 are already in a more advanced analysis process.
Among the companies that have already requested registration with Anvisa to produce their own GLP-1-based medicines are EMS, Hypera, Biomm, Eurofarma, Cimed and Eli Lilly.
Ozempic’s patent fall
A in Brazil, it opens the market for more than a dozen pharmaceutical companies to produce competitors for the medicine that has been used to control diabetes and lose weight. There is also an expectation for a price reduction in the market, which should reach 20% of the value in pharmacies.
According to Novo Nordisk, manufacturer of Ozempic, the Closing a patent is a natural step in the life cycle of any innovation. “The company is prepared to act solidly in this new context.”
In a statement, the company also said that innovation has been one of its central pillars for more than a century, and that it continues to guide its long-term strategy, translated into a portfolio of transformative medicines and a robust pipeline, with the potential to generate new relevant advances in the care of serious chronic diseases and contribute to stronger, resilient and sustainable health systems.
The company also said that the Brazil continues to be one of the most strategic markets for Novo Nordisk globally, and that its plan remains unchanged.
