Federal Register #FDA2025E0707

FDA Regulatory Review Period Determinations for DAYVIGO and BRINSUPRI Patent Extensions

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, announces regulatory review period determinations for two human drug products: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of the Commissioner - OEMs and Patent Holders: - Eisai R&D Management Co., Ltd. (DAYVIGO) - Insmed Incorporated (BRINSUPRI) - Products/Drugs: - DAYVIGO (lemborexant) - NDA 212028 - Indicated for adult insomnia (difficulty with sleep onset/maintenance) - BRINSUPRI (brensocatib) - NDA 217673 - Indicated for non-cystic fibrosis bronchiectasis in adults and pediatric patients 12+ - Notable Requirements: - Patent term restoration applications have been submitted for both drugs to the USPTO - FDA details the regulatory review periods, including testing and approval phases - Public comments and petitions are invited regarding the review periods and due diligence - A public advisory committee meeting is announced for GRAIL, Inc.'s Galleri device - No procurement of products or services is being requested or awarded in this notice

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product DAYVIGO (lemborexant), which is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This determination is published as required by law following the submission of an application to the U.S. Patent and Trademark Office (USPTO) for the extension of a patent claiming this drug product. The regulatory review period includes a testing phase and an approval phase, with specific dates verified by the FDA. Interested parties may submit comments or petitions regarding the determination or the applicant's due diligence during the regulatory review period.

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