Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto

The roller-coaster ride for Novartis—as it uses every bit of its legal muscle to extend Entresto's market exclusivity—took another zig on Thursday with a federal appellate court blocking the sale of a generic version of the heart failure blockbuster.

The U.S. Court of Appeals for the Federal Circuit ordered MSN Pharma of India to delay the launch of its Entresto generic “until further notice” as the court weighs Novartis’ bid to extend patent protection for its best-selling drug, according to a filing (PDF) published by Reuters.

The ruling came hours after the U.S. Court of Appeals for the District of Columbia Circuit lifted a block on the launch that it had enacted the day before, according to a separate filing (PDF).

Novartis’ legal wrangling with MSN dates to 2022, when it filed a patent infringement case against the Indian generic drugmaker and several others. More recently, MSN Pharma won FDA approval for its copycat last summer, prompting Novartis to seek an injunction barring the generic rollout.

Entresto’s importance to Novartis is illustrated in the company’s most recent quarterly report, which revealed that the drug generated $5.6 billion in the first three quarters of 2024, accounting for more than 15% of the company’s revenue. Sales continue to boom for the treatment as they were up 28% over the same period from 2023.