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

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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENFLONSIA 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 biological product.

Published

Apr 3, 2026

Comments Close

Jun 2, 2026(46d)

Citation

91 FR 16959

Agencies

2026-06479Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA

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Agencies (2)

FDA — Food and Drug Administration

HHS — Health and Human Services Department

Docket IDs

Docket No. FDA-2025-E-3626

Document Details

Type: Notice
Action: Notice.
Document #: 2026-06479
Citation: 91 FR 16959
Publication Date: Apr 3, 2026
Dates: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by June 2, 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 30, 2026. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
Federal Register Pages: Vol. 91, pp. 16959–16960
Page Views: 121

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