Sole Challenger HEC Beaten On US Gilenya Patent

Key Patent to December 2027 Upheld

Imminent generic competition to Novartis’ Gilenya blockbuster in the US now seems impossible after a US district court held that the company’s dosage-regimen patent was both valid and infringed by HEC’s ANDA product. The Chinese firm may yet appeal the decision.

Courtroom
HEC's dual challenge to Gilenya's dosage-regimen patent fell flat • Source: Shutterstock

Novartis’ US dosage-regimen patent 9,187,405 for Gilenya (fingolimod) 0.5mg capsules is not invalid and is also infringed by HEC Pharm’s proposed abbreviated new drug application product, a US district court has ordered, shooting down the potential for generic competition this year to the $1.8bn blockbuster.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

More from Generics Bulletin