Sughrue Mion Files Patent Term Extension Application for Otsuka Pharmaceutical
Summary
Sughrue Mion, PLLC filed a patent term extension application with FDA on behalf of Otsuka Pharmaceutical Co., Ltd. The application was submitted under the FDA-2026-E-4490-0002 docket and is associated with CDER (Center for Drug Evaluation and Research). No documents are currently available for public viewing or download on the regulations.gov docket page.
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What changed
A patent term extension application was filed by Sughrue Mion, PLLC representing Otsuka Pharmaceutical Co., Ltd. with FDA's Center for Drug Evaluation and Research. This represents an application filing only and does not constitute any final FDA action or determination on patent term extension eligibility.
Affected parties—primarily pharmaceutical companies with products undergoing FDA review—should monitor this docket for any substantive documents if and when they become available. The filing itself does not create any compliance obligations or deadlines for third parties.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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There are no documents available to view or download
Attachments 1
Patent Term Extension Application from Sughrue Mion, PLLC on behalf of Otsuka Pharmaceutical Co., Ltd.
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- Author(s) CDER
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