Federal Register #FDA-2025-E-0707

FDA Notice on Patent Extension and Regulatory Review Periods for BRINSUPRI and DAYVIGO

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, provides regulatory updates on patent term extensions for two human drug products: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of the Commissioner - OEMs and Vendors Mentioned: - Eisai R&D Management Co., Ltd (manufacturer of DAYVIGO) - Insmed Incorporated (manufacturer of BRINSUPRI) - GRAIL, Inc. (developer of Galleri device, referenced in advisory committee context) - Products/Services Requested: - No procurement of products or services is being requested or awarded in this notice - Regulatory review periods and patent extension applications for: - BRINSUPRI (brensocatib), NDA 217673, a DPP1 inhibitor for non-cystic fibrosis bronchiectasis - DAYVIGO (lemborexant), NDA 212028, an orexin receptor antagonist for adult insomnia - Announcement of a public advisory committee meeting regarding GRAIL, Inc.'s Galleri device - Unique or Notable Requirements: - The notice is informational, inviting public comments and petitions on the regulatory review periods and diligence of the applicants - No acquisition, purchase, or contracting action is being solicited - Patent extension durations and regulatory review periods are specified for both drugs

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product DAYVIGO (lemborexant), which is an orexin receptor antagonist 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 Director of 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 the FDA establishing the maximum potential length of a patent extension based on these periods. Interested parties may submit comments or petitions regarding the determination or the applicant's diligence during the regulatory review period by specified deadlines.

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