Bayer HealthCare Patent Extension US Patent 10428063
Summary
FDA granted a patent term extension for US Patent 10428063 assigned to Bayer HealthCare. The document was filed under docket FDA-2026-E-4532-0003 on regulations.gov. Patent term extensions compensate for regulatory review time and can extend market exclusivity for approved pharmaceutical products. Bayer HealthCare is the patent holder receiving the extension.
Pharmaceutical companies and ANDA applicants should monitor the Orange Book for newly extended patents, as extensions directly affect the timing of generic market entry. The extension of US Patent 10428063 means Bayer HealthCare retains market exclusivity longer than originally scheduled, and competitors should adjust launch timelines accordingly.
About this source
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What changed
FDA has extended the term of US Patent 10428063 assigned to Bayer HealthCare. Patent term extensions are granted under the Drug Price Competition and Patent Term Restoration Act, which allows patent owners to recover a portion of the time lost during FDA regulatory review. The extension applies to the remaining term of the patent from the date of FDA approval of the associated product.
Pharmaceutical companies and generic drug manufacturers should note that patent extensions delay generic competition for the covered product. Generic applicants, ANDA filers, and brand-name competitors should review Orange Book listings for extended patents when assessing entry dates for competing products.
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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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