Litigation Update: Brazil Court Confirms 2026 Expiry for Ozempic Patents
Posted on December 18, 2025
For pharmaceutical investors, patients, and generic manufacturers, here is the breakdown of the recent litigation landscape in Brazil.
The Core Decision: Extension Denied
Novo Nordisk, the manufacturer of Ozempic, had sought to extend the validity of its Brazilian patents beyond the standard 20-year term. Their argument was based on significant administrative delays by the Brazilian Patent and Trademark Office (INPI) in examining the original patent applications.
However, the Brazilian Federal Courts have ruled against these extensions. The decision leans heavily on the landmark Supreme Federal Court (STF) ruling (ADI 5529) from 2021.
The Legal Context: The ADI 5529 ruling declared the "sole paragraph" of Article 40 of Brazil’s Industrial Property Law unconstitutional. Previously, this law allowed for automatic patent extensions if the patent office took too long to grant approval. With this provision struck down, patents in Brazil now strictly expire 20 years from their filing date.
What This Means for the Market
With the extension denied, the "cliff edge" for Ozempic in Brazil is set for March 2026. This is significantly earlier than in the United States and Europe, where patent thickets protect semaglutide well into the 2030s.
The implications are immediate:
- Generic Entry: Brazilian pharmaceutical giants, including Hypera Pharma and partnerships involving Biomm (partnered with India's Biocon), have already announced readiness to launch generic semaglutide immediately upon patent expiry.
- Price Competition: The entry of generics is expected to drastically reduce the cost of the drug in Brazil, making it more accessible to a population with high obesity and diabetes rates.
- Global Disparity: This decision creates a fractured global market where Brazil (along with China and India) will see low-cost generics years before Western markets.
Key Takeaway
While Novo Nordisk continues to defend its intellectual property aggressively worldwide—suing medical spas and compounding pharmacies in the US—the legal avenue for extending their monopoly in Brazil appears closed.
As we move into 2026, all eyes will be on Brazil as a test case for how the introduction of generic semaglutide impacts patient access and the original manufacturer's market share.

Comments
Post a Comment