Changeflow GovPing Healthcare & Life Sciences VYLOY Patent Extension Notice Comment
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VYLOY Patent Extension Notice Comment

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Summary

FDA is accepting public comments on a patent term extension notice for VYLOY (cisplatin), a chemotherapy drug. Comments are being submitted through Regulations.gov docket FDA-2025-E-0863. The notice relates to potential patent term extension eligibility under the Drug Price Competition and Patent Term Restoration Act.

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

What changed

FDA has opened a public comment period on a patent extension notice for VYLOY (cisplatin), a branded chemotherapy medication. The comment form (FDA-2025-E-0863-0006) allows interested parties to submit feedback on the agency's patent term extension determination. The specific substance of the notice and any comments submitted are not contained in this form interface.

Pharmaceutical manufacturers, patent holders, and stakeholders wishing to submit comments on the VYLOY patent extension should use this Regulations.gov form to provide their input. Commenters should select their identity type (Individual, Organization, or Anonymous) and may attach supporting documentation up to 10MB. No specific comment deadline or compliance deadline is visible in this form.

Archived snapshot

Apr 3, 2026

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Last updated

Classification

Agency
FDA
Published
January 1st, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
FDA-2025-E-0863-0006
Docket
FDA-2025-E-0863

Who this affects

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

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Legal
Compliance frameworks
GxP
Topics
Intellectual Property Healthcare

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