← REGULATORY CHANGES
FEDERAL REGISTER · NOTICESeptember 9, 2026NOTICE — NO LEGAL EFFECTOPEN FOR COMMENT

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

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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.

Document type
Notice
Agency
Health and Human Services Department
Published
September 9, 2026
Comments close
March 8, 2027
Document number
2026-18298
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO 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 March 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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