Sughrue Mion Patent Term Extension Application for Otsuka Pharmaceutical
Summary
FDA received a patent term extension application from Sughrue Mion, PLLC on behalf of Otsuka Pharmaceutical Co., Ltd. The application was filed with CDER (Center for Drug Evaluation and Research) and is accessible via regulations.gov under docket FDA-2026-E-4457-0002. Patent term extensions compensate for regulatory review periods under the Hatch-Waxman Act.
“Patent Term Extension Application from Sughrue Mion, PLLC on behalf of Otsuka Pharmaceutical Co., Ltd.”
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What changed
Sughrue Mion, PLLC filed a patent term extension application with the FDA on behalf of Otsuka Pharmaceutical Co., Ltd. The application was submitted to CDER (Center for Drug Evaluation and Research) and is documented under docket number FDA-2026-E-4457-0002 on regulations.gov.
Affected parties include pharmaceutical companies seeking to extend patent terms for drug products subject to FDA regulatory review. Patent term extension applications are processed under the Hatch-Waxman Act framework, which allows for compensation of time lost during the FDA approval process. Stakeholders should monitor this docket for any substantive review actions or requests for additional information.
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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Patent Term Extension Application from Sughrue Mion, PLLC on behalf of Otsuka Pharmaceutical Co., Ltd.
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