FDA Sets ZEVTERA Review Dates in Routine Patent-Extension Notice
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the drug ZEVTERA, which helps the company extend its patent protection. This means the drug maker could get extra time to keep exclusive rights, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, they have until mid-2025 to speak up.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets ZEVTERA review period and extension request
FDA determined the regulatory review period for ZEVTERA is 7,790 days total, with 7,545 days in the testing phase and 245 days in the approval phase. FDA records show the IND effective date as December 7, 2002, the NDA was submitted on August 3, 2023, and approval occurred on April 3, 2024; the patent applicant seeks 1,863 days of patent term extension.
Public deadlines to challenge dates and diligence
Anyone may submit comments asking FDA to redetermine the published dates by August 15, 2025, and any interested person may petition FDA about whether the applicant acted with due diligence by December 15, 2025. Comments may be submitted electronically at https://www.regulations.gov (see Docket No. FDA-2024-E-3591) or as written/paper submissions to the Dockets Management Staff.
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