Novartis to appeal US Entresto patent decision

8 July 2023

Swiss pharma giant Novartis (NOVN: VX) yesterday announced that the US District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering its heart failure treatment Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity.

Novartis strongly believes the combination patent is valid and will appeal to the US Court of Appeals for the Federal Circuit (CAFC) to reverse the District Court’s decision. The company says it will continue to defend vigorously its intellectual property rights relating to Entresto, including the combination patent as well as multiple patents covering additional innovations.

Currently no generic Entresto products have tentative or final FDA approval, and the drug generated sales of $4.6 billion in 2022, a year-on-year rise of 37%.

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