Novartis prevails in US patent dispute over Entresto

14 January 2025

Swiss pharma giant Novartis (NOVN: VX) has expressed its satisfaction at a decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto (sacubitril/valsartan) combination patent.

Entresto is Novartis’ blockbuster heart failure drug. Its sales topped $6 billion in 2023 and now, thanks to the court ruling, market exclusivity will be maintained for the time being.

In 2019, MSN, among other generic manufacturers, submitted an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (FDA) approval to market and sell a generic version of Entresto. The MSN application was approved in July of last year.

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