1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

Skinny Label Limits: Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

 
• By Dave Wallace

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

The Supreme Court denied Norwich’s request to review its case. (Shutterstock)
Key Takeaways
  • The US Supreme Court refused to review Norwich Pharmaceuticals case that blocked FDA approval of a generic version of Bausch Health's Xifaxan.
  • Norwich was denied despite amending its ANDA to include a skinny label without a patent-protected indication.
  • The decision, made without comment, means the generic cannot be approved by the FDA until 2029.


Carving out a patent-protected indication could not save Norwich Pharmaceuticals from having its generic blocked from US Food and Drug Administration approval.

The US Supreme Court on 18 November denied without comment the company’s petition to review litigation from Bausch Health that prevented Norwich’s generic of Xifaxan (rifaximin) from approval until 2029.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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
Start Free Trial

Already a subscriber?

More from Generics

More from Patents