💊FDA Regulatory Review Period Determination for TRUQAP
Determination of Regulatory Review Period for Purposes of Patent Extension; TRUQAP
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRUQAP 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 document outlines the FDA's determination of the regulatory review period for the drug TRUQAP, which affects patent extension applications. This directly impacts businesses, particularly pharmaceutical companies like AstraZeneca, which may gain a competitive advantage through patent extensions, thus influencing market position and financial strategies.