💊FDA Announces Regulatory Review Period for MIPLYFFA Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MIPLYFFA 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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA’s announcement regarding the regulatory review period for MIPLYFFA directly impacts patent extension applications, which can influence market exclusivity and financial forecasts for companies in the pharmaceutical sector. The notice indicates potential compliance requirements around patent applications that need to be met by entities looking to market similar products.