WASHINGTON, Jan 15 - 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.