Patent Term Application for VYLOY (zolbetuximab-clzb), Patent No. 10,813,996 | Federal Regulations · Congress.wiki

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FDA-2025-E-0845

Patent Term Application for VYLOY (zolbetuximab-clzb), Patent No. 10,813,996

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OPEN

Comment Period OpensMar 24, 2025

Comment Period ClosesJun 3, 2026

Type	Title	Posted	Comments	Status
Notice	Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY FR Doc: 2026-06478	Apr 3, 2026	--

CDER

Patent Extension Application

VYLOY (zolbetuximab-clzb)

Neal, Gerber & Eisenberg LLP

Astellas Pharma Inc

TRON – Translationale Onkologie an der

Universitatesmedizin der Johannes

Gutenberg-Universitat Mainz Gemeinnutzige GmbH