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# FDA Denies Novartis Entresto Petition
- URL: https://www.fdaweb.com/fda-denies-novartis-entresto-petition-2/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157426

FDA has denied a Novartis 9/12/2022 petition asking that the agency not approve certain ANDAs that cite Entresto (sacubitril and valsartan) tablets in various doses as the reference-listed drug. Specifically, the petition asked that FDA:

- not approve any ANDA referencing Entresto until the 2/16/2024 expiration of its three-year exclusivity;
- not approve any ANDA citing Entresto that contains a section viii statement to three Novartis patents before their 8/22/2033 expiration; and
- not approve any ANDA referencing Entresto with a section viii reference to a different patent covering the dosing regimen in certain circumstances before its 5/9/2036 expiration.

The FDA [response](https://downloads.regulations.gov/FDA-2022-P-2228-0015/attachment%5F1.pdf?ref=fdaweb.com) says the first Novartis request is moot and the second and third requests are denied. The letter says that ANDA applicants may submit a request that covers indications other than those protected by an existing patent and can submit a modified dosing regimen not covered by an existing patent.