1. Generics Bulletin
  2. >>Products
  3. >>Generics

Gilenya Generics May Be Imminent Amid US Federal Circuit Snub

HEC May Face US Supreme Court Date As Novartis Loses Again

 
• By Dean Rudge

Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.

US-Supreme-Court_V1_1200
Novartis intends to take its fight to the Supreme Court • Source: Shutterstock

Generic versions of Novartis’ Gilenya (fingolimod) blockbuster treatment for multiple sclerosis, including lone litigator HEC Pharm’s ANDA product, may flood the US market imminently, following a favorable decision by the US Court of Appeals for the Federal Circuit.

Novartis’s concession came as HEC Pharm scored another legal victory over the Swiss originator in the firms’ long-running Gilenya patent-litigation...

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
Start Free Trial

Already a subscriber?

More from Generics

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By Dean Rudge

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

More from Products

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By Dean Rudge

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.