💊FDA Determines Regulatory Review Period for QALSODY Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; QALSODY
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QALSODY 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 drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's determination of the regulatory review period for QALSODY has direct implications on potential patent term extensions, impacting business strategy for companies involved in pharmaceuticals. The determination aids businesses in understanding the patent landscape and might affect market positioning and investment decisions.