US appeals court lifts pause on generic version of Novartis’ Entresto

By Blake Brittain

WASHINGTON – Drugmaker MSN Pharmaceuticals cleared another hurdle on Thursday toward launching its generic version of Novartis (SIX:NOVN)’ blockbuster heart-failure drug Entresto after a U.S. appeals court ended a temporary pause on MSN’s launch.

The U.S. Court of Appeals for the District of Columbia Circuit lifted the pause less than 24 hours after it started, potentially freeing MSN to launch its generic in the U.S. amid an ongoing patent dispute between the companies.

Spokespeople and an attorney for Novartis did not immediately respond to a request for comment and more information on the ruling. An attorney for MSN declined to comment.

India-based 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.

Entresto is Switzerland-based Novartis’ best-selling drug, which brought the company more than $6 billion in revenue in 2023.

The U.S. Court of Appeals for the Federal Circuit last week reversed a 2023 decision 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 expired and MSN said that the ban would end.

The Federal Circuit and U.S. district courts in Washington and Delaware rejected Novartis requests for a mandate that would immediately block the generic.

The D.C. Circuit paused MSN’s launch on Wednesday night to consider Novartis’ bid for a longer delay as the court hears an appeal related to the FDA’s approval of the generic.

A three-judge D.C. Circuit panel lifted the pause on Thursday and denied Novartis’ request for a ban on the launch for the duration of the appeal.