Novartis Fails to Block MSN’s Entresto Generic Launch

Legal Ruling:
A Delaware district court ruled against Novartis, denying its bid for a preliminary injunction to block the launch of MSN Pharmaceuticals' generic version of Entresto, a heart failure drug.

Patent Dispute:
The dispute centers around the amorphous solid compound TVS (sacubitril, valsartan, and sodium cations), which is patent-protected until November 2026. Novartis claimed MSN's generic product infringes on this patent, but the court found insufficient evidence to support this claim.

FDA Approval:
MSN received final FDA approval for its generic Entresto in July 2024. The FDA denied Novartis' citizen petition to prevent the approval of Entresto generics, suggesting that drug applicants can modify their labeling to avoid patent infringement.

Financial Impact:
Novartis argued that allowing MSN's generic to enter the market could lead to significant financial losses, including lost sales, market share, and formulary positioning. However, the court was skeptical about these claims and did not find them sufficient to justify an injunction.

Market Impact:
Entresto is one of Novartis' top-selling drugs, generating over $6 billion in sales in 2023. The entry of generics is expected to impact Novartis' sales projections for 2024 and beyond.

Future Legal Actions:
Novartis has been granted a temporary stay to appeal the decision to the U.S. Court of Appeals, indicating that the legal battle is not yet over.