Federal Register #FDA-2025-E-3939

FDA Regulatory Review Period Determination for ANZUPGO (delgocitinib) Patent Extension

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, addresses the regulatory review period determination for the drug ANZUPGO (delgocitinib) for patent extension purposes. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEM/Vendor: - Japan Tobacco Inc. (patent holder and manufacturer of ANZUPGO) - Product Details: - ANZUPGO (delgocitinib) - Indicated for topical treatment of moderate to severe chronic hand eczema in adults - For patients with inadequate response to, or for whom topical corticosteroids are not advisable - Regulatory Review Period: - Testing phase: 3,167 days - Approval phase: 365 days - Total: 3,532 days - Unique/Notable Requirements: - Notice is issued in response to a patent extension application to the U.S. Patent and Trademark Office (USPTO) - Public comments and petitions are invited regarding the accuracy of the review period and applicant's due diligence - No procurement or contract award is being announced; this is a regulatory notice related to patent extension.

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product ANZUPGO (delgocitinib), which is used for the topical treatment of moderate to severe chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. This determination is published as required by law following the submission of an application to the U.S. Patent and Trademark Office (USPTO) for patent extension. The regulatory review period consists of a testing phase of 3,167 days and an approval phase of 365 days, totaling 3,532 days. The FDA invites comments and petitions regarding the dates and due diligence of the applicant during the regulatory review period.

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