← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEMay 12, 2025NOTICE — NO LEGAL EFFECT

Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEJul 11, 2025 · closed
APPLIES TO · SPEQ TAGBiologics
Document type
Notice
Agency
Health and Human Services Department
Published
May 12, 2025
Comments close
July 11, 2025
Document number
2025-08256
Docket
FDA-2024-E-0210
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Abstract as published in the Federal Register.

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