VYLOY Patent Extension Comment Period

Regs.gov: Food and Drug Administration

Published May 1st, 2025

Detected April 3rd, 2026

Summary

FDA has opened a public comment period on a patent term extension application for VYLOY (citizens乏 details unspecified). Comments on FDA-2025-E-0866-0006 must be submitted by June 2, 2025. This consultation allows interested parties to provide input on the patent extension determination.

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What changed

FDA has published a consultation notice seeking public comments on a patent term extension application for the drug VYLOY (docket FDA-2025-E-0866-0006). Patent term extensions are granted under the Drug Price Competition and Patent Term Restoration Act to compensate for regulatory review time. The comment period closes on June 2, 2025.

Pharmaceutical companies and patent holders with interests in drug patent terms should review the application and submit any relevant comments before the deadline. Parties may wish to verify the accuracy of the extension term calculation or supporting documentation. Failure to comment during the open period may limit opportunities to contest the extension determination.

What to do next

Review patent extension application details in the docket before commenting
Submit comments via regulations.gov by June 2, 2025 if you have relevant information or objections
Verify accuracy of patent term calculation and supporting documentation

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