Patent Extension Application for Ascendis Pharma Growth Disorders A/S
Summary
Alston & Bird LLP filed a patent term extension application with the FDA on behalf of Ascendis Pharma Growth Disorders A/S. The application was submitted to CDER for review and is accessible via Regulations.gov docket FDA-2026-E-4540-0002. No substantive regulatory changes are associated with this procedural filing.
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What changed
This docket entry documents the filing of a new patent term extension application by Alston & Bird LLP on behalf of Ascendis Pharma Growth Disorders A/S with the FDA's Center for Drug Evaluation and Research. The application is accessible via Regulations.gov as a downloadable attachment. No regulatory requirements or compliance obligations are created by this filing. Patent term extension applications are administrative proceedings that restore patent term lost during the FDA regulatory review process.
Affected parties include pharmaceutical companies seeking to extend patent protection for drugs undergoing FDA review. Competitors monitoring patent portfolios should note this filing as it may affect the exclusivity timeline for growth disorder treatments developed by Ascendis Pharma. Legal and regulatory affairs teams at pharmaceutical firms should ensure patent term extension strategies align with Hatch-Waxman Act requirements when applicable.
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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Attachments 1
Patent Term Extension Application from Alston & Bird LLP on behalf of Ascendis Pharma Growth Disorders A/S
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- Author(s) CDER
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