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Priority review Consultation Added Consultation

ENFLONSIA Patent Extension Consultation

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Summary

The FDA is seeking public comments on an ENFLONSIA patent extension application (Docket FDA-2025-E-3626-0006). Comments must be submitted by June 2, 2025 via Regulations.gov. This consultation follows standard FDA procedures for pharmaceutical patent-related matters.

What changed

The FDA has opened a public comment period on a patent extension application for ENFLONSIA, a pharmaceutical product. The comment period closes on June 2, 2025. Interested parties may submit comments through the Regulations.gov portal using docket number FDA-2025-E-3626-0006.

Pharmaceutical manufacturers, patients, and other stakeholders wishing to provide input on the ENFLONSIA patent extension should submit comments via Regulations.gov before June 2, 2025. No specific compliance obligations are created by this consultation; it is a standard FDA process for gathering public input on patent matters.

Archived snapshot

Apr 3, 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.

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Public Comments on Federal Regulations

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Last updated

Classification

Agency
FDA
Comment period closes
June 2nd, 2025 (closed 318 days ago)
Instrument
Consultation
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
FDA-2025-E-3626-0006
Docket
FDA-2025-E-3626-0006

Who this affects

Applies to
Pharmaceutical companies Patients Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent Extension Review
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Intellectual Property Consumer Protection

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