Alston and Bird Patent Extension for Ascendis Pharma Growth Disorders
Summary
Alston and Bird LLP filed a Patent Term Extension application with the FDA on behalf of Ascendis Pharma Growth Disorders A/S. The filing, assigned docket FDA-2026-E-4539-0002, has been logged in the regulations.gov system. The application seeks to extend the patent term for a product related to growth disorders, a process available under the Hatch-Waxman Act to compensate for regulatory review time. The document record references an attachment containing the full application materials.
About this source
Every FDA document on regulations.gov, the federal rulemaking portal. This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot. Around 240 a month. FDA's heavy regulations.gov use means tracking only the Federal Register misses a meaningful chunk of what the agency does day-to-day. Watch this if you manufacture devices, submit IND or NDA applications, run a lab, or advise sponsors on FDA process. GovPing publishes each posting with the docket, document type, division (CDER, CDRH, CFSAN), and comment window where one applies.
What changed
The FDA has received and logged a Patent Term Extension application filed by Alston and Bird LLP on behalf of Ascendis Pharma Growth Disorders A/S. Patent Term Extensions under 35 U.S.C. §156 compensate patent holders for regulatory review delays during the drug approval process. The application has been assigned a docket number and is accessible via regulations.gov. Parties interested in the substantive application details should download the attached PDF filing.
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.
Content
There are no documents available to view or download
Attachments 1
Patent Term Extension Application from Alston and Bird LLP on behalf of Ascendis Pharma Growth Disorders A/S
More Information
- Author(s) CDER
Download
Related changes
Get daily alerts for Regs.gov: Food and Drug Administration
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when Regs.gov: Food and Drug Administration publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.