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Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC

9 October 2026

In plain English

FDA has determined the regulatory review period for the drug MONOFERRIC, following a patent extension application filed with the USPTO.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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

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