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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NIKTIMVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological product.

Tags

information blocking, Notice, Health and Human Services Department, Food and Drug Administration

Related exam domains

None matched

Source record id

2025-18809

First seen by InfoSec Signals

9/23/2026

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