Federal Register #FDA-2025-E-3626

FDA Notice on ENFLONSIA Patent Extension Regulatory Review Period

This notice from the Food and Drug Administration (FDA) provides information on the regulatory review period for ENFLONSIA (clesrovimab-cfor), a human biological product for preventing RSV lower respiratory tract disease in infants. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Merck Sharp & Dohme LLC (applicant for patent extension) - Product Referenced: - ENFLONSIA (clesrovimab-cfor) - Indication: Prevention of RSV lower respiratory tract disease in neonates and infants - Notable Details: - The notice is related to a patent extension application submitted to the U.S. Patent and Trademark Office (USPTO) - The regulatory review period is established as 2,956 days (testing and approval phases) - No procurement of products or services is requested; this is an informational notice regarding patent extension eligibility - Agencies Involved: - FDA (regulatory review) - USPTO (patent extension process) - Place of Record: - FDA office, Rockville, MD

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product ENFLONSIA (clesrovimab-cfor), which is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. This determination is published as required by law following an application to the U.S. Patent and Trademark Office (USPTO) for patent extension. The regulatory review period was found to be 2,956 days, including testing and approval phases, establishing the maximum potential length of a patent extension for this product.

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