1. Generics Bulletin

MSN Has Green Light To Launch US Entresto Competition, With Trial Around The Corner

US Appeals Court Upholds Denial Of Preliminary Injunction; Key 2026 Patent At-Issue

 
• By Dean Rudge

Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.

Appeal_Gavel
The US Court of Appeals for the Second Circuit backed the district court’s dismissal

Just days before trial is set to begin in overarching patent-infringement proceedings, MSN Laboratories has again dodged an attempt by Novartis to enjoin the Indian firm’s US Food and Drug Administration-approved generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, setting up the potential for an ‘at-risk’ launch.

The US Court of Appeals for the Federal Circuit on 4 December affirmed a lower court’s decision to deny a preliminary injunction, writing that the district court did not...

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