Judge Rejects Novartis Bid to Delay Entresto Generic

The ruling, issued Friday by U.S. District Judge Richard Andrews in Delaware, marks a significant setback for the Swiss drugmaker. Novartis had argued that MSN’s proposed generic would infringe on one of its patents and requested an injunction to block the launch until after the patent’s expiration in November 2026. However, the judge dismissed that claim, per Reuters, effectively paving the way for MSN to move forward with its plans.

According to a court filing cited by Reuters, Novartis informed the court that India-based MSN could receive approval from the U.S. Food and Drug Administration (FDA) for its generic version as early as July 16. That timeline suggests MSN may introduce its product into the market in the very near future.

Entresto, a leading treatment for heart failure, has been a top earner for Novartis, generating over $7.8 billion in global revenue in 2023 alone. The entrance of a generic version is likely to erode Novartis’ market share in the U.S., where Entresto plays a pivotal role in the company’s pharmaceutical portfolio.

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Following the court’s decision, Novartis shares dropped more than 2% during Friday morning trading. The company expressed disappointment in the ruling and stated that it plans to appeal, according to Reuters.

This decision follows a separate development earlier this year, in which Novartis successfully persuaded the U.S. Court of Appeals for the Federal Circuit to temporarily block MSN’s generic launch until July as part of another patent dispute.

MSN Pharmaceuticals has not publicly commented on the latest ruling.

The case is drawing attention in the ongoing debate around “pay-for-delay” tactics and brand-name drugmakers’ efforts to extend market exclusivity through litigation.

Source: Reuters