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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYALEV 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 drug product.

Abstract as published in the Federal Register.

The comment window is still open until December 28, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.