Novartis wins Entresto patent lawsuit
- Novartis (NYSE:NVS) won a lawsuit challenging its use of an Entresto patent listing in the FDA’s Orange Book.
- A U.S. federal judge dismissed claims that the company improperly delayed generic competition for the heart-failure drug.
- Entresto sales declined after U.S. patents expired and generic versions entered the market.
Novartis (NYSE:NVS) won a lawsuit in Manhattan federal court after a judge dismissed claims that the company improperly used an Entresto patent listing to delay generic competition.
U.S. District Judge Lewis Liman ruled that the patent was properly listed in the FDA’s Orange Book, rejecting claims brought by drug purchasers.
The lawsuit, filed by Iron Workers Local 580 Insurance Fund on behalf of Entresto purchasers, alleged that Novartis improperly listed a patent covering the drug and delayed generic competition by at least six months.
The plaintiffs argued that the delayed competition resulted in higher prices and more than $2 billion in additional U.S. Entresto sales for Novartis, while the company maintained that the patent listing complied with regulatory requirements.
Entresto remains Novartis’ best-selling drug, but company reports showed sales declined 42% to $1.31 billion in the first quarter of 2026 after U.S. patent protection expired and generic versions entered the market.
