Novartis Fails To Prevent Generic Competition For Its Blockbuster Multiple Sclerosis Drug

The U.S. Supreme Court rejected Novartis AG's NVS effort to block the launch of generic versions of its multiple sclerosis drug Gilenya.
Reportedly, Novartis sued HEC and several other generic drugmakers, accusing them of patent infringement, in Delaware federal court after they applied for FDA approval of Gilenya generics.
According to a Reuters report, Novartis had asked the justices to suspend a lower court's ruling that lifted a ban on generic versions of Gilenya.
Related: Novartis Dodges Whistleblower Lawsuit Regarding Multiple Sclerosis Drug Kickback Claims.
Gilenya was the third highest-selling drug for Novartis in 2021.
Novartis settled with some of the drugmakers it had sued, allowing for some Gilenya generics before a key patent's 2027 expiration. Companies that settled with Novartis included India-based Aurobindo Pharma Ltd, Dr. Reddy's Laboratories Ltd RDY, Sun Pharmaceutical Industries Ltd, Viatris Inc's VTRS Mylan Pharmaceuticals, and privately held Apotex Inc.
The FDA approved Gilenya in 2010 as a once-daily pill used to treat relapsing forms of multiple sclerosis, a chronic disease that affects the central nervous system.
Novartis said in September that it expects to lose $300 million in sales for the rest of 2022 if the Gilenya generics are launched.
Price Action: NVS shares are up 0.05% at $76.05 during the premarket session on the last check Friday.

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