Novartis is going after the FDA over the agency’s decision to approve a generic version of the cardiovascular drug Entresto earlier this year.
The Swiss drugmaker sued the government after the FDA in late July rejected the company’s citizen petition for the second time. The chronic heart failure drug brought in more than $6 billion in 2023 sales.
In the July 30 lawsuit filed in a DC federal court, Novartis said the FDA’s approval of the generic from MSN Laboratories and denial of Novartis’ two citizen petitions to stop it is “unlawful.” Novartis claimed the new label for the generic doesn’t have safety information that’s in Entresto’s labeling; that the FDA rewrote the drug’s approved indication in order to avoid Novartis’ patent; and that the FDA has decided that the generic can contain forms of Entresto’s two active ingredients that aren’t present in Novartis’ version of the drug.
“Time is of the essence in this case,” the company wrote. “MSN’s approval permits MSN to flood the market at any moment, creating imminent and irreparable harm to Novartis.” It’s seeking a temporary restraining order.
The FDA told Endpoints News that it doesn’t comment on pending litigation. A spokesperson for Novartis said the company also asked the court to make the FDA rescind its approval of the generic application.
Entresto is also part of the first round of 10 drugs that have gone through price negotiations with the federal government under the Inflation Reduction Act. The new prices will be revealed on Sept. 1, and would go into effect in 2026. Novartis joined other large pharma companies that sued the government last year over the inclusion of their drugs in the negotiations.