FDA Times FILSUVEZ Review for Patent Life Extension
Published Date: 12/10/2025
Notice
Summary
The FDA has officially set the review period for FILSUVEZ, a new drug, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until early 2026 to speak up.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
FDA Sets FILSUVEZ Review Period
FDA determined the regulatory review period for FILSUVEZ is 1,929 days in total — 935 days in the testing phase and 994 days in the approval phase. Key dates used were: IND effective September 8, 2018 (FDA found; applicant claimed September 5, 2018), NDA initially submitted March 30, 2021, and NDA approval on December 18, 2023. This determination establishes the maximum potential length of a patent extension for this drug and could affect when generic versions can enter the market.
Company Seeks 1,463-Day Patent Extension
The patent applicant for FILSUVEZ is seeking 1,463 days of patent term extension; the FDA's determination sets the maximum potential extension but the U.S. Patent and Trademark Office will apply statutory limitations when calculating the actual extension awarded. If granted, the requested 1,463-day extension would extend the period of exclusivity before generics may enter the market.
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Key Dates
Department and Agencies
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