FDA Sets Clock for ENSACOVE Patent Extension Review
Published Date: 3/6/2026
Notice
Summary
The FDA has officially set the review period for ENSACOVE, a human drug, so its patent holder can apply for extra patent time. This affects the drug company and anyone tracking patent extensions, with deadlines to challenge dates or diligence claims by May 5 and September 2, 2026. It’s a key step to keep innovation protected while making sure the process stays fair and on schedule.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA Sets ENSACOVE Review Period
FDA determined ENSACOVE’s regulatory review period is 4,645 days total (4,288 days testing phase and 357 days approval phase). The determination uses an IND effective date of April 2, 2012, an NDA submission date of December 28, 2023, and an approval date of December 18, 2024; the applicant seeks 1,827 days of patent term extension.
Deadline to Seek Redetermination
Anyone who believes the published dates are incorrect may submit electronic or written comments and ask FDA for a redetermination by May 5, 2026. Electronic comments are accepted at https://www.regulations.gov until 11:59 p.m. Eastern Time on May 5, 2026; mailed paper comments must be received by that date to be timely.
Deadline to Petition on Due Diligence
Any interested person may petition FDA to determine whether the patent applicant acted with due diligence during the regulatory review period; petitions must be filed by September 2, 2026 and comply with 21 CFR 60.30 and related requirements. Petitions must be timely, follow submission rules in 21 CFR 10.20, contain sufficient facts, and certify service on the patent applicant.
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