Novartis wins temporary pause to Entresto generic launch in US

By Blake Brittain

WASHINGTON -A federal appeals court temporarily paused drugmaker MSN Pharmaceuticals' launch of a generic version of Novartis' blockbuster heart-failure drug Entresto late on Wednesday.

The U.S. Court of Appeals for the District of Columbia Circuit halted the launch, which could have begun as early as Thursday, while it considers Novartis' emergency request for a longer pause.

A separate ruling on Wednesday from U.S. District Judge Dabney Friedrich in Washington had cleared a hurdle for MSN to introduce the first U.S. generic of Switzerland-based Novartis' best-selling drug, which brought the company more than $6 billion in revenue in 2023.

An attorney for MSN declined to comment on the decisions. An attorney and spokespeople for Novartis did not immediately respond to requests for comment.

MSN's version of Entresto was approved by the U.S. Food and Drug Administration last year.

Novartis sued MSN and others seeking to launch Entresto generics for patent infringement. The U.S. Court of Appeals for the Federal Circuit last week reversed a 2023 decision by a Delaware judge that invalidated one of the patents.

Novartis argued in a court filing that the appeals court ruling maintained the company's exclusive rights to sell Entresto until July. The company said MSN was preparing to launch its generic on Thursday, when Novartis' patent expires and MSN said that the ban would end.

The Federal Circuit on Tuesday rejected Novartis' request for a mandate that would immediately block the generic.

Novartis separately sued the U.S. Food and Drug Administration in Washington federal court on Monday to block the launch. Friedrich said she would reject Novartis' request during a hearing late on Wednesday.

(Reporting by Blake Brittain in Washington; Editing by David Bario, Stephen Coates and Jamie Freed)