Viatris and others become latest targets of Novartis' Entresto patent litigation

2022-10-26

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Novartis protects its blockbusters like a bear and her cubs, recently taking a Gilenya patent battle all the way to the Supreme Court. Now it’s filing yet another federal court complaint in an attempt to drive off Entresto generics. Viatris and Mylan are among Novartis’ latest targets, as well as Alembic Pharmaceuticals, Crystal Pharmaceutical, MSN Pharmaceuticals and Nanjing Noratech Pharmaceutical. The company argued in a new lawsuit on Monday that abbreviated NDAs filed by the defendants for generic versions of 24 mg and 26 mg Entresto tablets infringe on a patent dubbed ‘918 that expires in November 2026. Novartis said it would be “substantially and irreparably damaged” if the generics are allowed to proceed, and asked the court to bar any approvals before the ‘918 patent expires. This isn’t the first time Novartis has taken Entresto competitors to court — and the company recently petitioned the FDA (for a second time) not to approve Entresto generics, citing potential label discrepancies. Entresto was first approved back in 2015 for the treatment of heart failure, and has since won an expanded indication in chronic heart failure and one in pediatric heart failure. It raked in more than $1.1 billion last quarter alone, and Novartis previously boasted a $5 billion peak sales potential. But if the company doesn’t get its way in court, more than a dozen generics may rain on that parade. The news comes as CEO Vas Narasimhan rolls out a “pure-play” strategy, culling thousands of staffers and spinning out generics unit Sandoz in an attempt to remold the company into a top-five player in the US. Entresto, Kesimpta and Kisqali play important roles in that transformation, the company made clear in a Q3 call this week. So does Gilenya, the company said, adding that it will petition the Supreme Court to uphold a key patent that expires in 2027. The multiple sclerosis drug was once one of the company’s top sellers, and generic rivals could cost Novartis more than a quarter billion dollars this year, the company previously said.

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