Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied Novartis’ request for an injunction to halt sales of the generic, a decision the company is appealing in the U.S. Court of Appeals.
In response to the approval, Novartis has filed a lawsuit against the FDA in Washington, D.C., seeking an injunction against MSN. The lawsuit contends that the labeling of MSN’s generic product “inappropriately rewrites Entresto’s approved indication” and reverts to outdated indications to circumvent Novartis’s patents. The company also claims that MSN’s version lacks critical safety information.
Entresto remains Novartis’ flagship product, generating USD 6.0 billion in sales in 2023, with a robust year-on-year growth of 31%. Novartis is focused on delaying the entry of generics until the full expiration of its Orange Book patents in 2026.- Flcube.com
