VYLOY Patent Extension Notice Comment

Regs.gov: Food and Drug Administration

Published January 1st, 2025

Detected April 3rd, 2026

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.

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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.

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