Novartis to Challenge US Court Ruling on Generic Entresto Version

Novartis AG plans to appeal a US court decision on the generic version of Entresto, a medication for heart failure. The company is one of the world's leaders in pharmaceuticals, with a strong presence in oncology, immunology, and cardiovascular diseases. Novartis had net sales of over $50 billion in 2024, with a significant presence in Europe and the US. The company has over 30 production sites worldwide.

Novartis AG, a global leader in pharmaceuticals, has announced its intention to appeal a recent court decision that allows MSN Pharmaceuticals to launch a generic version of its blockbuster heart-failure drug, Entresto. The Swiss-based company, with a significant presence in Europe and the United States, faces potential market disruption and financial challenges as a result of the ruling.

On July 1, 2025, U.S. District Judge Richard Andrews denied Novartis' request to block MSN's generic Entresto from entering the market until after the patent expires in November 2026. The judge's decision rejected Novartis' argument that MSN's generic would infringe on one of its patents. This ruling accelerates the erosion of Entresto's patent-protected monopoly, which has been a significant revenue generator for Novartis [1].

The decision has significant financial implications for Novartis. Entresto accounted for 11% of Novartis' 2024 revenue, and analysts estimate a 50–70% sales decline by 2026 once generics enter the market. This could result in a substantial loss of revenue for the company. Additionally, the Inflation Reduction Act (IRA) adds a second threat by imposing Medicare price caps on high-priced medications, further squeezing Novartis' margins [2].

Novartis' stock has been negatively impacted by the ruling, with shares down more than 2% on July 1, 2025. The company has stated that it is disappointed with the decision and plans to appeal. Spokespeople for MSN did not immediately respond to requests for comment [1].

The legal battle between Novartis and MSN has been ongoing since October 2022. Novartis initially sought to delay MSN's generic launch by exploiting the Hatch-Waxman Act's provisions. However, the Delaware court's decision exposed critical flaws in Novartis' patent strategy. The court found that MSN's formulation did not infringe on Novartis' patent covering the amorphous solid form of sacubitril-valsartan [2].

Investors and financial professionals should closely monitor the appeal process and the potential impact of generic competition on Novartis' financial performance. The company's ability to pivot to newer therapies, such as gene therapies and cell-based oncology drugs, may offer long-term opportunities. However, in the near term, Entresto's decline is expected to continue, potentially leading to margin compression and market share loss [2].

References:
[1] https://pharma.economictimes.indiatimes.com/news/pharma-industry/novartis-faces-setback-as-court-allows-msn-pharmaceuticals-to-launch-entresto-generic/122399736
[2] https://www.ainvest.com/news/entresto-patent-fallacy-novartis-faces-7-8b-revenue-tsunami-2507/