Novartis cannot prevent generic competition for its blockbuster

Novartis cannot prevent generic competition for its blockbuster


  • The US Supreme Court refused of Novartis AG NVS Efforts to block the launch of generic versions of its multiple sclerosis drug Gilenya.
  • Novartis reportedly sued HEC and several other generic drug makers in federal court in Delaware after they applied for FDA approval of Gilenya generics, accusing them of patent infringement.
  • According to a Reuters report, Novartis asked the judges to stay a lower court’s decision overturning a ban on generic versions of Gilenya.
  • Related: Novartis Dodges Whistleblower Lawsuit Over Multiple Sclerosis Drug Kickback Claims.
  • Gilenya was Novartis’ third best-selling drug in 2021.
  • Novartis settled with some of the drugmakers being sued and allowed some Gilenya generics before a key patent expires in 2027. Companies that settled with Novartis included India-based companies Aurobindo Pharma Ltd, dr Reddy’s Laboratories Ltd RDY, Sun Pharmaceutical Industries Ltd, Viatris Inc VTRS Mylan Pharmaceuticalsand privately owned Apotex Inc.
  • The FDA approved Gilenya in 2010 as a once-daily pill to treat relapsing forms of multiple sclerosis, a chronic disease that affects the central nervous system.
  • Novartis said in September that it expects $300 million in lost sales for the remainder of 2022 as Gilenya’s generics come to market.
  • Price promotion: NVS shares are up 0.05% to $76.05 during the premarket session last Check Friday.

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