14 May 2025

💊FDA Determines Regulatory Review Period for ADBRY Patent Extension

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

Summary

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

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$$ - High

The FDA’s determination of the regulatory review period and patent extension implications for ADBRY directly affects pharmaceutical companies and business owners involved in drug development and patent management. This decision may influence investment strategies and market positioning due to the potential for extended patent protection.

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