# 2025-23862: FDA Sets Timer for ROMVIMZA Patent Extension Bid

2025-23862, Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective 2025-12-29 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23862
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23862
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60721
- Published: 2025-12-29
- Effective: 2025-12-29
- Comments close: 2026-02-27
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Sets Timer for ROMVIMZA Patent Extension Bid

## Summary

The FDA has set the official review period for the drug ROMVIMZA, which helps the company extend its patent protection. This means the drug maker could get more time to exclusively sell ROMVIMZA, potentially affecting competition and profits. People can challenge the dates or the company’s effort in the review process by early and mid-2026 deadlines.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROMVIMZA 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

- ROMVIMZA review period set: mixed, medium. FDA determined ROMVIMZA had a 3,020-day regulatory review period: 2,777 days in the testing phase and 243 days in the approval phase. FDA verified key dates: IND effective November 10, 2016; NDA submitted June 17, 2024; NDA approved February 14, 2025, and the applicant seeks 1,632 days of patent te…
- Public deadlines to challenge dates: benefit, low. Anyone who believes the published dates are wrong may ask FDA for a redetermination by February 27, 2026. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by June 29, 2026.
- Law allows up to 5-year patent extension: benefit, medium. Under the governing statutes, a patent may be extended for up to 5 years when the patented product was subject to FDA regulatory review before marketing. FDA's determination of the regulatory review period forms the basis for calculating any extension.

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## Sources
- [2025-23862 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23862/determination-of-regulatory-review-period-for-purposes-of-patent-extension-romvimza)
- [2025-23862 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23862.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-23862 (as of 2026-06-08).