14 Jul 2025
💊FDA Announces Regulatory Review Period for LAZCLUZE Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; LAZCLUZE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAZCLUZE 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 regulatory determination of the review period for the LAZCLUZE drug impacts patent extension opportunities, potentially influencing market exclusivity and financial planning for stakeholders in the pharmaceutical industry. This affects compliance requirements and patent strategy for business owners in this sector.