FDA Sets ENCELTO Review Period for Patent Padding
Published Date: 4/3/2026
Notice
Summary
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets ENCELTO review period
The FDA determined ENCELTO's regulatory review period is 7,903 days in total — 7,581 days in the testing phase and 322 days in the approval phase. The key dates are: IND effective July 18, 2003; BLA submitted April 18, 2024; BLA approved March 5, 2025. This determination establishes the maximum potential length of a patent extension, and the applicant is seeking 950 days of patent term extension.
Deadlines to challenge dates or diligence
Anyone who believes the published dates are wrong may submit comments and ask FDA for a redetermination by June 2, 2026 (electronic filing accepted until 11:59 p.m. ET that day). Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by September 30, 2026.
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Key Dates
Department and Agencies
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