Novartis Faces Legal Setbacks Against MSN's Entresto Generic Amid Market Challenges

Novartis is embroiled in ongoing legal battles as it seeks to defend its heart failure medication, Entresto, against generic competition from MSN Pharmaceuticals. Despite Entresto's status as a blockbuster drug, generating over $6 billion in global sales last year, Novartis has suffered several legal defeats in its effort to maintain market exclusivity. A significant blow came when a federal appeals court denied Novartis's attempt to block MSN's generic version, following the FDA's approval of MSN's Entresto generic in July 2024[1][2]. Novartis argued that the generic infringes on its patent, which is valid until 2026, and feared irreparable harm from MSN's potential market entry[1]. However, both the district court and the appeals court found Novartis's claims unconvincing[2]. As the company navigates these legal challenges, it also contends with additional pressures, including the Inflation Reduction Act's drug price negotiation program, which targets Entresto for price regulation starting in 2026[2].