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

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.

More from Legal & IP

Glenmark Dodges UK Dapagliflozin Injunction Ahead Of Patent Trial Decision

 
• By 

A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.

Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
• By 

Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Five-Year Extension Found Just, As Aurobindo Loses On US Sugammadex Appeal

 
• By 

In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.

MSN’s US Entresto Generic Blocked In Part For Being Too Similar To The Brand

 
• By 

Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.

More from Generics Bulletin

Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

 

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.