12 May 2025
💊FDA Determines Regulatory Review Period for LITFULO Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO 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 determination of the regulatory review period for LITFULO influences the potential for patent extension, impacting pharmaceutical companies like Pfizer. This affects financial projections, market exclusivity, and business planning related to drug development and marketing.