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# Court Should Deny Novartis Injunction Request: FDA
- URL: https://www.fdaweb.com/court-should-deny-novartis-injunction-request-fda/
- Published: 2024-08-07T12:00:00.000Z
- Updated: 2026-09-14T14:37:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157528

Responding to a recent Novartis lawsuit against FDA that seeks a preliminary injunction to reverse its approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), the agency says the motion should be denied because the company has not met its burden to show that it is “entitled to extraordinary emergency relief.”

Novartis’ lawsuit ([see earlier story](https://www.fdaweb.com/novartis-sues-fda-to-reverse-generic-entresto-ok/)) argues that FDA’s conduct in approving the generic product and denying two citizen petitions submitted by Novartis is 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that it may approve generic labeling that inappropriately rewrites Entresto’s approved indication and reverts to a superseded indication in an effort to avoid Novartis’s patents,” it says.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.

FDA’s [opposition filing](http://www.fdaweb.com/download.php?file=FDA%5Fnovartis%5Fresponse.pdf) says there is “no legal or logical basis for Novartis’s claim that generic labeling may only omit a patented use by deleting words from (rather than adding them to) the reference drug’s labeling. Rather, the question under the \[Food, Drug & Cosmetic Act\] and FDA’s regulations is whether the substance of the change omits a patent-protected use. And with respect to the dosage carve out, Novartis has not shown that FDA acted arbitrarily or capriciously when it applied its scientific expertise to determine that omitting Novartis’s patent-protected modified dosing regimen would not make MSN’s generic product less safe or effective than Entresto for its remaining unprotected uses.”

Additionally, FDA contends that Novartos has not shown that it will suffer irreparable harm without emergency relief. It says the company has claimed that it would lose about 5% of its $45 billion in annual sales if the generic stays on the market. “That is not the sort of devastating harm that courts in the DC Circuit have found to be irreparable,” the agency’s brief says.