Court Blocks MSN's Generic Entresto Launch Amid Patent Battle

The U.S. Court of Appeals has temporarily halted MSN Pharmaceuticals' launch of a generic version of Novartis' heart-failure drug Entresto. This follows Novartis' appeal to maintain exclusive sales rights. The legal battle involves patent infringement claims as Novartis races against time before patent expiration.

The U.S. Court of Appeals for the District of Columbia Circuit temporarily paused the rollout of MSN Pharmaceuticals' generic version of Novartis' heart-failure medication, Entresto. This decision, made late Wednesday, comes amid Novartis' emergency plea for an extended pause to preserve its market exclusivity.

While U.S. District Judge Dabney Friedrich had previously allowed MSN to introduce Entresto's first U.S. generic variant, Novartis plans to appeal, citing patent infringement issues. The Swiss drugmaker earned over $6 billion in revenue from Entresto in 2023 alone. Attorneys from both companies have remained tight-lipped regarding the rulings.

The legal tug-of-war intensifies as Novartis also contests the U.S. Food and Drug Administration's approval of MSN's version. Despite a prior Delaware court decision favoring MSN, the U.S. Court of Appeals for the Federal Circuit overturned it, asserting Novartis' patent rights until July. Novartis concurrently filed a lawsuit against the FDA to block MSN's launch, but Judge Friedrich seems poised to dismiss it.

(With inputs from agencies.)