💊FDA's Regulatory Review Period for TALVEY Patent Extension Announced
Determination of Regulatory Review Period for Purposes of Patent Extension; TALVEY
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TALVEY 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 regulation establishes the patent extension period for TALVEY, which impacts business owners in the pharmaceutical industry by affecting market exclusivity and financial forecasting related to patent expirations. The deadline for public comments and petitions may involve stakeholders needing to comply with regulatory requirements.