Drugs

FDA Denies Novartis Entresto Petition

David McFarland

— 1 min read
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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 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.

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