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Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE | Sporos

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Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENSACOVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Published

Mar 6, 2026

Comments Close

May 5, 2026(18d)

Citation

91 FR 11075

Agencies

2026-04491Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE

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Agencies (2)

FDA — Food and Drug Administration

HHS — Health and Human Services Department

Docket IDs

Docket No. FDA-2025-E-0493

Document Details

Type: Notice
Action: Notice.
Document #: 2026-04491
Citation: 91 FR 11075
Publication Date: Mar 6, 2026
Dates: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by May 5, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 2, 2026. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
Federal Register Pages: Vol. 91, pp. 11075–11077
Page Views: 123

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