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# Novartis Wins Generic Entresto Approval Stay
- URL: https://www.fdaweb.com/novartis-wins-generic-entresto-approval-stay/
- Published: 2024-08-21T12:00:00.000Z
- Updated: 2026-09-14T14:39:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157627

The United States Court of Appeals for the DC Circuit has granted a Novartis motion to stay FDA’s approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan) until it rules on the matter, which is related to a labeling carve-out dispute.

In July, Novartis ([see story](https://www.fdaweb.com/novartis-sues-fda-to-reverse-generic-entresto-ok/)) filed a lawsuit against FDA to reverse the generic’s approval, arguing that the agency’s conduct in approving the product and denying two citizen petitions submitted by Novartis was unlawful. “FDA has asserted that it may approve generic labeling that inappropriately rewrites Entresto’s approved indication and reverts to a superseded indication in an effort to avoid Novartis’s patents,” the lawsuit says. By doing this, Novartis says the agency violated its implementing regulations, which provide that generic labeling may omit an indication that is subject to patent rights, but not add wording or make other changes to an indication remaining in the labeling.

On 8/13, the Washington DC District Court [denied](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2024cv2234-23&ref=fdaweb.com) a Novartis motion for a temporary restraining order or a preliminary injunction to stay FDA’s approval of the disputed generic product. In seeking the temporary restraining order while the case advances, Novartis offered three theories of irreparable harm, but the lower court said “none of them rise to such imminence and severity as to meet this circuit’s ‘high bar’ for the ‘extraordinary remedy’ of preliminary injunctive relief.” It added that the court has committed to “resolving the merits of this action on an expedited basis — within the next 60 days or less — so any harm that Novartis purports to suffer will be short-lived.”