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US appeals court lifts pause on generic version of Novartis' Entresto
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US appeals court lifts pause on generic version of Novartis' Entresto
Jan 16, 2025 1:29 PM

WASHINGTON, Jan 16 - Drugmaker MSN Pharmaceuticals

cleared another hurdle on Thursday toward launching its generic

version of Novartis' 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.

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