← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEAugust 10, 2026NOTICE — NO LEGAL EFFECTOPEN FOR COMMENT

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

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Document type
Notice
Agency
Health and Human Services Department
Published
August 10, 2026
Comments close
February 8, 2027
Document number
2026-16246
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYVIGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.

Abstract as published in the Federal Register.

The comment window is still open until February 8, 2027. The comment window is open. Check the document itself for what comments are being solicited on and what weight they carry. Submit comments through the Federal Register document below.

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