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US appeals court reinstates pause on generic version of Novartis' Entresto
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US appeals court reinstates pause on generic version of Novartis' Entresto
Jan 16, 2025 3:11 PM

WASHINGTON, Jan 16 - Novartis won an order from

a U.S. appeals court in Washington on Thursday temporarily

blocking drugmaker MSN Pharmaceuticals from launching a generic

version of Novartis' blockbuster heart-failure drug Entresto.

The U.S. Court of Appeals for the Federal Circuit ordered

MSN not to launch its drug while it considers Novartis' request

for a longer ban on the generic version.

The decision marks the latest change in fortune for

Novartis amid multiple eleventh-hour bids to block MSN's

generic, which Novartis said MSN could launch as early as

Thursday.

The Federal Circuit's ruling comes hours after the U.S.

Court of Appeals for the District of Columbia Circuit

lifted a similar pause

on the launch that had gone into effect Wednesday night.

Spokespeople and an attorney for Novartis did not

immediately respond to requests for comment and more information

on the rulings. 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 Federal Circuit last week reversed a 2023 decision that

invalidated one of the patents. Novartis argued in a court

filing that the ruling maintained the company's exclusive rights

to sell Entresto until July.

The company said MSN was preparing to launch its generic on

Thursday, the day Novartis' patent expired.

U.S. district courts in Washington and Delaware rejected

Novartis' requests on Wednesday for a mandate that would

immediately block the generic.

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