Novartis loses legal battle to block US Entresto generic until 2026

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-07-12 06:53 GMT   |   Update On 2025-07-12 06:53 GMT
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Washington: In a significant legal setback for Novartis, a Delaware federal judge has said that Swiss pharmaceutical giant cannot stop Indian drugmaker MSN Pharmaceuticals from launching a generic version of Entresto, its blockbuster heart-failure medication, before a key patent expires in late 2026.

U.S. District Judge Richard Andrews issued the ruling on Friday, denying Novartis’ request for an injunction that would have prevented MSN from launching its generic drug until after the patent’s expiration in November 2026. The judge rejected Novartis’ claim that MSN’s version would infringe on its patents, Reuters reported.

Novartis told the court in a separate filing on Friday that India-based MSN may receive U.S. Food and Drug Administration approval for the generic as soon as July 16 and launch it soon after. The generic would cut into the U.S. market for Swiss-based Novartis' best-selling drug, which earned more than $7.8 billion in global revenue last year.

Read also: Novartis receives USFDA accelerated approval for Vanrafia for proteinuria reduction in primary IgA nephropathy

Novartis stock was down more than 2% on Friday morning. The company said in a statement that it was disappointed and planned to appeal.
Novartis had convinced the U.S. Court of Appeals for the Federal Circuit in January to halt MSN's launch of its generic until July in a separate patent case.
Adding further pressure to Novartis for its blockbuster heart failure drug, the Medical Dialogues team reported in January that
 Lupin, 
another Indian generics manufacturer, had received USFDA approval for its generic version of Sacubitril and Valsartan Tablets.
Formed in 1996, Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland. Novartis was formed by the merger of Ciba-Geigy and Sandoz.
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