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Novartis wins temporary pause to Entresto generic launch in US
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Novartis wins temporary pause to Entresto generic launch in US
Jan 15, 2025 6:24 PM

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.

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