FDA Determines EMRELIS Patent Review, Challenges Welcome
Published Date: 4/3/2026
Notice
Summary
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Sets EMRELIS Review Period
The FDA determined the regulatory review period for the biologic EMRELIS is 5,027 days total — 4,797 days in the testing phase and 230 days in the approval phase. Based on those dates, the patent applicant is seeking 727 days of patent term extension for U.S. Patents 10,383,948 and 10,603,389; the BLA was submitted on September 27, 2024 and approved on May 14, 2025.
Deadlines To Challenge Dates or Diligence
Anyone who thinks the dates published for EMRELIS are wrong must ask for a redetermination by June 2, 2026. Any interested person may petition FDA about whether the patent applicant acted with due diligence during the regulatory review period by September 30, 2026, following the procedures in 21 CFR 60.24 and 60.30.
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