Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Determination of regulatory review period for purposes of patent extension of biologic ESPEROCT, (Mar 23, 2023)

By WK Editorial Staff

The FDA determined the regulatory review period for ESPEROCT and published the notice of that determination as required by law.

The FDA has approved for marketing the human biologic product ESPEROCT (antihemophilic factor (recombinant), glycopegylated-exei). ESPEROCT is indicated for use in adults and children with hemophilia A for: (1) on-demand treatment and control of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to reduce the frequency of bleeding episodes. The FDA 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 (Notice, 88 FR 16992, March 21, 2023).

Dates. Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination by May 22, 2023. 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 21, 2023.

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