Federal Register #FDA-2025-E-5206

FDA Notice on Regulatory Review Period for BRINSUPRI (brensocatib) Patent Extension

This notice from the Food and Drug Administration (FDA) provides information on the regulatory review period for the drug BRINSUPRI (brensocatib), manufactured by Insmed Incorporated, as part of the patent extension process. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEM Highlight: - Insmed Incorporated is the manufacturer of BRINSUPRI (brensocatib) - Product Details: - BRINSUPRI (brensocatib), a dipeptidyl peptidase 1 (DPP1) inhibitor - Indicated for treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients aged 12 years and older - Regulatory Review Period: - Testing phase: 2,679 days - Approval phase: 243 days - Total: 2,922 days - Purpose: - Notice relates to the process for patent extension following an application to the U.S. Patent and Trademark Office (USPTO) - FDA invites public comments and petitions regarding this determination - No procurement or award is being made; this is an informational notice only

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product BRINSUPRI (brensocatib), which is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. This determination is part of the process for patent extension following the submission of an application to the U.S. Patent and Trademark Office (USPTO). The regulatory review period includes a testing phase of 2,679 days and an approval phase of 243 days, totaling 2,922 days. The FDA invites comments and petitions regarding the dates of the regulatory review period until specified deadlines.

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