Novartis files lawsuit against FDA over generic Entresto
Novartis recently filed a lawsuit against the Food and Drug Administration in a federal court in Washington, D.C., claiming that the FDA's approval of a generic version of Entresto is unlawful, per a Fierce Pharma report.
Entresto, an oral treatment which is a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan, was approved by the FDA in 2015.
The complaint follows the FDA granting permission to MSN Laboratories for an Entresto generic product.
The FDA also rejected a Novartis generated Citizen Petition, which requested the FDA block the entrance of generic versions of Entresto.
The petition, which was submitted in September 2022, had asked the FDA to deny the approval of any Entresto generic until Feb. 16, 2024. It also petitioned to prevent the FDA from approving any Entresto generics that would violate Novartis patents due to expire in 2033 and 2036, per the report.
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The FDA rejected the first request because it has already passed. The second and third requests were denied because the FDA said that generics can avoid infringement simply by adjusting their labels, per the report.
Novartis owns a series of patents on the drug, with some expiring in 2025, 2026 and 2027, according to FDA records, the report said.
In its complaint, Novartis alleges the FDA’s conduct is unlawful because it encourages labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis also argues that MSN’s label for its generic “deletes critical safety information contained in the Entresto labeling.” Additionally Novartis contends that the FDA, in denying Novartis’ petition, has “bound itself to approved generics that do not have identical active ingredients to Entresto,” per the report.