💊FDA Notice on Regulatory Review Period for VELSIPITY Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; VELSIPITY
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELSIPITY 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 notice involves the regulatory review period for the drug VELSIPITY, impacting the patent extension process, which affects drug pricing, competition, and potential revenue for businesses. The ability for companies to seek patent extensions can influence market dynamics and investment decisions in the pharmaceutical industry.