Novartis Faces Major Setback, $6 Billion Drug Market Under Threat

Novartis is trying to do everything possible to keep a generic version of its blockbuster heart failure drug Entresto off the U.S. market. Despite numerous legal hurdles, the company has failed to gain regulatory approval. In the process, U.S. District Judge Dabney Friedrich made clear in an order issued Tuesday that the Food and Drug Administration (FDA) did not overstep its authority when it approved MSN Pharmaceuticals to make a generic version of Entresto, despite slight and alleged discrepancies in the labeling of the two drugs.

Novartis said in a statement that it disagreed with the ruling and had decided to appeal. MSN Pharmaceuticals and the FDA were not immediately available for comment.

Entresto is one of Novartis' top-selling drugs, bringing in more than $6 billion in revenue last year alone. A generic version of Entresto, made by MSN Pharmaceuticals, received FDA approval last month, marking the first generic version of the drug on the market in the United States.

Novartis had previously filed a separate patent infringement lawsuit against MSN Pharmaceuticals and lost in August to block the launch of a generic version of MSN. Still, MSN Pharmaceuticals is barred from launching its generic version because Novartis appealed the order.

Shortly after the FDA approved MSN Pharmaceuticals' application to sell a generic version of Entresto, Novartis filed a lawsuit against the FDA in July, claiming that the approval was arbitrary and capricious and violated the Federal Food, Drug, and Cosmetic Act (FDCA) in multiple ways. However, as the case moved forward, Judge Dabney Friedrich rejected Novartis's claim that the FDA's approval was based on its reasonable interpretation of the federal Food, Drug, and Cosmetic Act, rather than following the FDA's opinion.

Novartis also argued that MSN Pharma's generic version is not exactly the same as Entresto because it is a simple mixture of two active ingredients, rather than linking two molecules together in a crystal structure. However, Judge Friedrich noted that under FDA's long-standing guidance, "different physical forms do not preclude proof of the same active ingredient," and stressed the authority of FDA's scientific judgment.

Notably, the background to this case is a lawsuit between Novartis and MSN Pharmaceuticals, case No. 1:24-cv-02234, U.S. District Court for the District of Columbia. Novartis was represented by Susan Cook, Kathryn Stetson and Marlan Golden of Hogan Lovells, while the FDA was represented by Gabriel Schonfeld of the U.S. Department of Justice. MSN Pharmaceuticals is represented by Polsinelli Law firm, including Chad Landmon, Suzanne Bassett, Corey Casey and Kendall Gurule.

Despite Novartis' legal attempts to block MSN Pharma's generic from entering the market, the judge's ruling shows that the FDA's approval was based on sound legal and scientific grounds, and Novartis' road to appeal remains challenging.