The patent loss of semaglutide last week is still being challenged in court by Novo Nordisk, manufacturer of Ozempic. The company asked the Superior Court of Justice (STJ) for answers after the court’s decision not to “reset the deadline” for the end of the exclusivity of producing the molecule in Brazil.
The company argues that this is not an extension, but a request to recover a 13-year gap in administrative processing of the patent application at the National Institute of Industrial Property (INPI). Officially, the patent .
In Brazil, a medicine can be manufactured exclusively using its developer’s technology for 20 years until the patent expires. The deadline starts from the request, and not from the approval, which led Novo Nordisk to request that exclusivity be maintained for another 12 years, compensating for the period of regulatory procedures.
The request was unanimously denied by the STJ in December last year. Now, the manufacturer confirms that it has presented additional questions to the decision via Motion for Clarification — procedural resources for clarification.
“Novo Nordisk never requested an extension. The company requested the restoration of the effective period of exclusivity guaranteed by the patent, which ended up being consumed by the bureaucratic process”, said the company in a note to InfoMoney.
For the rapporteur of the case, Isabel Gallotti, the patent holder is not unprotected during the period of processing of the administrative process at the INPI, being assured the right to obtain compensation for undue exploitation from the date of publication of the request, and not just from the granting of the letter patent.
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Non-market impact of semaglutide
A change in the exclusivity period would impact the expectations of the Brazilian pharmaceutical industry. The National Health Surveillance Agency (Anvisa) published a notice in the second half of 2025 prioritizing the evaluation of products analogous to GLP-1 (classification given to semaglutide), but the first request reached the agency in 2023.
On the day of the molecule’s patent loss, the National Health Surveillance Agency (Anvisa) reported that there are currently eight processes under analysis for new medicines based on the active ingredient of Ozempic. Seven of them are of synthetic origin and one of biological origin. Nine more processes are awaiting analysis by the technical areas.
O InfoMoney asked for an update on the status of orders, but Anvisa did not respond until the article was published.
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In March, the president of Hypera, Breno de Oliveira, said that the company could be the first to receive the release. The executive — discounting compounding pharmacies.
Other projections point to an even larger market: , potentially exceeding US$160 billion by 2030.
Strategically, Brazil is one of Novo Nordisk’s main global markets. Around 25% of the company’s global insulin production comes from its factory in Montes Claros (MG) — equivalent to approximately 12% of the insulin consumed in the world. The factory will also expand national production of injectable medicines.
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Despite the scenario, the company says it sees Ozempic’s patent loss as a natural stage in the life cycle of any innovation. “The company is prepared to act solidly in this new context, and continues to innovate to offer increasingly better medicines to people, delivering greater health and well-being in the long term”, he states.
Dispute over liraglutide
In October 2025, Novo Nordisk and Eurofarma began a partnership to strengthen the distribution and promotion of injectable biological semaglutide in Brazil. The Brazilian pharmaceutical company is the exclusive distributor for the marketing and promotion of two new brands of high-quality weekly injectable biological semaglutide on the Brazilian market: Poviztra, indicated for the treatment of obesity, and Extensior, intended for the treatment of type 2 diabetes.
In another process similar to the one analyzed by the STJ, Novo Nordisk requested the restoration of the patent for another molecule, liraglutide — the active ingredient in weight-loss pens such as Victoza and Saxenda — for a period of 8 years, 5 months and one day. This time, the Federal Court of the Federal District granted an injunction to maintain the patent, recognizing the delay in granting the patent by the INPI.
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“Novo Nordisk is awaiting a decision on an appeal pending evaluation in the case regarding liraglutide, so it is not possible to anticipate whether a precedent favorable to the recomposition of the patent term will be consolidated”, responded to the company about the possibility that the case will help in the dispute over semaglutide.
“The company reiterates that it supports legislative modernization, through the implementation of the Patent Term Adjustment (PTA) mechanism in the national legal system, aiming to ensure that Brazil remains a safe environment for new investments in science,” he said.
