Novartis' Attempt to Block Generic Rival Fails in US Court

Novartis AG has been ruled against by a US court in an attempt to block the launch of a generic rival drug. The ruling is a significant blow to the Swiss pharmaceutical company, which relies heavily on its pharmaceutical products for revenue. Net sales break down by therapeutic area, with oncology being the largest contributor. Novartis has over 30 production sites worldwide and a significant presence in the US market.

Title: Novartis Faces Setback as US Court Allows Generic Entresto to Launch

A U.S. federal court has dealt a significant blow to Novartis AG (NYSE: NVS) by denying the Swiss pharmaceutical giant's attempt to block the launch of a generic version of its blockbuster heart failure drug, Entresto. The ruling, issued by U.S. District Judge Richard Andrews in Delaware, paves the way for India-based MSN Pharmaceuticals to introduce its generic version of Entresto, potentially eroding Novartis' market share in the U.S.

The dispute centered on Novartis' U.S. Patent No. 11,096,918, which the company claimed had been infringed by MSN's Abbreviated New Drug Application (ANDA). However, the judge ruled that MSN's ANDA and its products do not infringe claim 1 of the '918 Patent, which is set to expire in November 2026. This decision is a setback for Novartis, which has been actively attempting to delay the generic launch through various legal means.

Entresto, a leading treatment for heart failure, generated over $7.8 billion in global revenue in 2024. 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. Following the court's decision, Novartis shares dropped more than 2% during Friday morning trading, reflecting investor concerns about the potential impact on the company's revenue.

Novartis 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.

[1] https://seekingalpha.com/news/4466900-novartis-loses-patent-challenge-block-generic-entresto
[2] https://www.pymnts.com/cpi-posts/judge-rejects-novartis-bid-to-delay-entresto-generic/