VYLOY Regulatory Review Period Patent Extension Comment Form

Detected April 3rd, 2026

Summary

FDA opened a public comment period on the regulatory review period patent extension for VYLOY (vonoprazan), a potassium-competitive acid blocker approved for gastric acid-related conditions. Comments are being accepted through regulations.gov docket FDA-2025-E-0845. Stakeholders may submit comments on behalf of themselves, organizations, or anonymously.

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What changed

The FDA has made available a public comment form for stakeholders to submit feedback on the regulatory review period patent extension for VYLOY (vonoprazan), a drug product subject to patent term extension provisions under the Hatch-Waxman Act. The comment form is hosted on regulations.gov and allows individuals, organizations, or anonymous commenters to submit input on the proceeding.

Pharmaceutical companies, patent holders, generic manufacturers, healthcare providers, and patients may use this form to submit comments to the FDA docket. Comments should address the regulatory review period calculation or related patent extension matters. No specific compliance deadline is provided for this consultation; the comment period closes once the agency reviews submitted feedback. This is an administrative consultation mechanism rather than a substantive regulatory action.

What to do next

Review the FDA docket FDA-2025-E-0845 to understand the specific patent extension issue under consideration
Prepare and submit comments through regulations.gov if your organization has relevant input on the VYLOY patent extension
Monitor the docket for any FDA responses or updates following the comment period

Source document (simplified)

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