💊FDA Announces Regulatory Review Period for SKYCLARYS Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS 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 FDA's determination of the regulatory review period for SKYCLARYS has critical financial implications for Reata Pharmaceuticals and other stakeholders, as it affects patent term extensions which influence market exclusivity and revenue potential. The upcoming opportunities for public comment and petitions regarding the determination could invite industry responses that may alter regulatory perceptions.