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 LtdDr. Reddy's Laboratories Ltd RDYSun Pharmaceutical Industries LtdViatris 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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