# 2026-16246: FDA Clocks Review Time for DAYVIGO Sleep Aid Patent Extension

2026-16246, Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-10, effective Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by October 9, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 8, 2027. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information. (as of 2026-08-17).

- Canonical: https://policyrisk.com/federal-register/2026-16246
- As of: 2026-08-17
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16246
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 51494
- Published: 2026-08-10
- Effective: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by October 9, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 8, 2027. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
- Comments close: 2027-02-08
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-08-17

## In one line

FDA Clocks Review Time for DAYVIGO Sleep Aid Patent Extension

## Summary

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYVIGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

## Effects PRIA read

No economic effects identified for this document.

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## Sources
- [2026-16246 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/10/2026-16246/determination-of-regulatory-review-period-for-purposes-of-patent-extension-dayvigo)
- [2026-16246 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-10/pdf/2026-16246.pdf)

## Related
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- [Next: 2026-16247, Determination of Regulatory Review Period for Purposes of Patent Extension; BRI…](https://policyrisk.com/federal-register/2026-16247)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16246 (as of 2026-08-17).