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Novartis loses emergency bid to block Entresto generic in US
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Novartis loses emergency bid to block Entresto generic in US
Jan 15, 2025 4:03 PM

WASHINGTON, Jan 15 - A Washington, D.C. federal judge on

Wednesday refused Novartis' eleventh-hour bid to block

drugmaker MSN Pharmaceuticals from launching a generic version

of Novartis' blockbuster heart-failure drug Entresto.

The decision by U.S. District Judge Dabney Friedrich clears

a hurdle for MSN to introduce the first U.S. generic version 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 decision. An

attorney and spokespeople for Novartis did not immediately

respond to a request 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.

MSN told the appeals court that the ban would expire on

Thursday regardless of the decision.

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. The FDA responded on Wednesday that only the courts

hearing the patent case could halt it.

Friedrich agreed with the FDA and said she would reject

Novartis' request during a hearing late Wednesday.

A separate Novartis emergency request to pause the launch is

still pending in the U.S. Court of Appeals for the District of

Columbia Circuit.

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