Changeflow GovPing Government & Legislation Patent Term Extension Application for Visterra,...
Routine Notice Added Final

Patent Term Extension Application for Visterra, Inc.

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Summary

Patent Term Extension Application for Visterra, Apr 10

Published by FDA on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The FDA published a notice on Regulations.gov announcing a patent term extension application submitted by Sterne, Kessler, Goldstein & Fox P.L.L.C. on behalf of Visterra, Inc. The application (FDA-2026-E-3826-0002) relates to a pharmaceutical patent and was filed with CDER.\n\nAffected parties include pharmaceutical and biotech companies seeking to extend patent terms for drug products under the Hatch-Waxman Act. This is a procedural filing notice; no compliance obligations or deadlines are established by this document. Stakeholders may monitor the docket for any further FDA action on the application.

What to do next

  1. Monitor for FDA decision on patent term extension application

Archived snapshot

Apr 10, 2026

GovPing 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

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Attachments 1

Patent Term Extension Application from Sterne, Kessler, Goldstein & Fox P.L.L.C (on behalf of Visterra, Inc.)

More Information
- Author(s) CDER
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Last updated

Classification

Agency
FDA
Published
April 10th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2026-E-3826-0002
Docket
FDA-2026-E-3826-0002

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers
Industry sector
3254.1 Biotechnology
Activity scope
Patent term extension filing
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Pharmaceuticals

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