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Aiming to block Entresto generics, Novartis sues Mylan, Alembic and others for patent infringement

In its latest effort to defend against forthcoming Entresto copycats, Novartis is taking to U.S. federal court to allege infringement against several generics players.

In a new lawsuit, Novartis sued Viatris subsidiary Mylan plus Alembic, Crystal Pharmaceutical, MSN Pharmaceuticals and Nanjing Noratech. Those companies are seeking FDA approval for their generic versions of blockbuster heart drug Entresto, but Novartis alleges infringement of its ‘918 patent, which is set to expire in November 2026.

Novartis claims it will be “irreparably damaged” by the generic companies’ attempts to win regulatory approvals for their products. The Swiss drugmaker asked the District Court of Delaware to halt potential approvals until no earlier than the Nov. 8, 2026, patent expiration.

A Viatris spokesperson didn’t immediately respond to a request for comment.

It’s not Novartis’s first attempt to defend Entresto. Last December, the company filed a lawsuit against Torrent Pharma, alleging patent infringement when Torrent submitted its generic application. The company argued that if Torrent were to move forward with production, it would be doing so knowing its actions constitute patent infringement, which would be “substantially and irreparably” damaging to Novartis.

Meanwhile, last month, the company petitioned the FDA to not approve generics of the drug until the end of its three-year exclusivity period that lasts until February 2024. That move followed a similar but unsuccessful appeal last November.

Last year, Entresto garnered nearly $3.55 billion in global sales. The company has maintained that the drug could deliver peak sales of $5 billion.