Legal Showdown: Novartis vs. Generic Entresto

A federal judge in Washington, D.C. denied Novartis' attempt to block MSN Pharmaceuticals from launching a generic version of its top-selling heart-failure drug, Entresto. This decision allows MSN to proceed with the release, affecting Novartis' monopoly as its patent expires.

In a significant legal development, a federal judge in Washington, D.C. rejected Novartis' attempt to prevent MSN Pharmaceuticals from launching a generic version of the heart-failure medication, Entresto. The ruling signifies a pivotal moment for MSN as it paves the way for the introduction of the first U.S. generic iteration of the drug, which had generated over $6 billion in revenue for the Swiss-based pharmaceutical giant, Novartis, in 2023.

MSN's version of the drug received approval from the U.S. Food and Drug Administration last year, despite Novartis' efforts to stifle its rollout through litigation over patent infringements. The dispute escalated when the U.S. Court of Appeals for the Federal Circuit reversed a Delaware judge's decision to invalidate one of Novartis' patents last week, maintaining the company's rights to sell Entresto until the upcoming expiration of their patent.

Even as Novartis sought further legal recourse to delay the generic's release, including suing the FDA, the court upheld its stance that only the patent case proceedings could impede the launch. On Wednesday, Judge Dabney Friedrich aligned with this view, allowing MSN's Thursday launch, further intensifying Novartis' legal entanglements as it awaits an emergency request decision in the district's circuit court.

(With inputs from agencies.)