Novartis loses legal battle to block US Entresto generic until 2026

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-07-12T12:23:24+05:30 | Updated On 12 July 2025 12:23 PM IST

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.

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.

Read also: Lupin's Generic Entresto Approved by USFDA, Set to Rival Novartis' Bestseller

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.

novartisnovartis newsMSN labsheart failure drugentrestopatent infringement

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751