Judge Rules Against Novartis' Effort To Halt Generic Launch Of Its Top-Selling Heart Disease Drug

Novartis AG NVS reportedly faced a legal setback as it failed to convince a federal court to block MSN Pharmaceuticals from launching a generic version of its heart-failure drug, Entresto.

On Monday, U.S. District Judge Richard Andrews in Delaware ruled that Novartis’ likelihood of winning its patent-infringement lawsuit was too low to justify stopping MSN Pharmaceuticals’ launch.

Also Read: Novartis Sues to Block Maryland’s New Drug Discount Law.

Despite this ruling, the judge temporarily suspended MSN Pharmaceuticals’ sales while Novartis appealed to the U.S. Court of Appeals for the Federal Circuit.

Entresto is Novartis’ top-selling drug. In the second quarter, it generated sales of $1.89 billion, up 25% year over year (+28% on constant currency).

The FDA approved MSN Pharmaceuticals’ version of Entresto in July, making it the first generic available in the U.S.

Novartis, which initially sued MSN Pharmaceuticals and other companies in 2022 over patent infringement, requested a preliminary injunction on August 2 to halt MSN Pharmaceuticals’ launch, but the court denied this request.

Reuters noted that Judge Andrews dismissed Novartis’ concerns about potential “irreparable harm” that could arise from a wave of generic launches by other manufacturers if MSN Pharmaceuticals’ version were released.

The judge’s ruling places additional pressure on Novartis, now considering “all available options” to defend its intellectual property rights.

Despite the legal challenges, the company maintains its financial outlook for 2024.

As the legal battle continues, Novartis has also sought to block MSN Pharmaceuticals’ launch through a separate lawsuit in a Washington, D.C. district court, challenging the FDA’s decision to approve the generic. The outcome of that case remains pending.

Price Action: NVS stock is up 0.25% to $111.69 at the last check on Tuesday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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