Novartis Secures Temporary Block on Generic Version of Entresto
Temporary Block:
Novartis obtained a temporary order from the US Court of Appeals for the Federal Circuit, preventing MSN Pharmaceuticals from launching a generic version of Entresto, a blockbuster heart failure drug45.
Legal Background:
Novartis had previously lost appeals and emergency bids to block the generic version, with courts ruling that Novartis had not sufficiently proven patent infringement123.
Entresto Sales:
Entresto is Novartis' top-selling asset, generating over $6 billion in net global sales last year1.
Patent Exclusivity:
Novartis sought to protect its patent exclusivity, which expires in 2033 and 2036 for specific patents related to Entresto1.
FDA Decision:
The FDA rejected Novartis' petition to block generic applications, stating that generics could avoid patent infringement by tweaking their labeling1.
Recent Developments:
Despite initial losses, Novartis secured a temporary block on January 16, 2025, temporarily halting the launch of the generic version45.
Sources:
1. https://www.biospace.com/policy/novartis-loses-appeal-to-bar-entresto-generic-from-u-s-market
2. https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-loses-emergency-bid-to-block-Entresto-generic-in-US-48777573/
3. https://public.com/posts/novartis-loses-emergency-bid-to-block-entresto-generic-in-us-6593862749
4. https://www.moomoo.com/news/post/48229635/novartis-obtains-temporary-court-order-blocking-generic-version-of-entresto
5. https://www.pharmalive.com/us-appeals-court-reinstates-pause-on-generic-version-of-novartis-entresto/