Novartis’ attempt to stop MSN Pharmaceuticals from launching a generic version of its blockbuster heart drug Entresto has hit yet another roadblock after a federal judge denied Novartis’ request for a preliminary injunction.
On Monday, US District Judge Richard Andrews in Delaware ruled that Novartis “has not shown it is likely to succeed on the merits of showing infringement” of Entresto’s patent. Andrews also rejected Novartis’ argument that allowing generics would cause “irreparable harm.”
However, Andrews did allow a three-day hold on the case to give Novartis time to appeal to the Federal Circuit. Novartis’ Entresto patent expires on Nov. 8, 2026.
In a statement to Endpoints News, Novartis said that the company is “considering all available options to vigorously defend our intellectual property rights,” and said that any launch by MSN right now “would be at risk of later litigation developments.”
Entresto is one of Novartis’ top-selling drugs, bringing in more than $6 billion in 2023 sales, with $1.9 billion in the first quarter and $1.8 billion in the second quarter of this year. Novartis also raised its 2024 guidance in July, writing that net sales are expected to grow in the high single- to low double-digit range, though it said that the guidance is dependent on whether Entresto generics enter the market.
The heart failure treatment is also part of the first round of 10 drugs that have gone through price negotiations with the federal government under the Inflation Reduction Act.
Earlier this month, Novartis sued the FDA after it approved MSN’s Entresto generic in July. The lawsuit follows the FDA’s denials of two citizen petitions from Novartis asking the agency not to approve the generic.
In its lawsuit against the FDA, Novartis claimed that the FDA’s denial of the citizen petitions was unlawful and cited issues with the generic’s labeling.