Windtree receives advice from IP, FDA on exclusivity strategy for istaroxime

Windtree Therapeutics (WINT) announces it has received advice from intellectual property and FDA experts highlighting a U.S. strategy that can provide 7.5 years of U.S. exclusivity for istaroxime if it is approved by the FDA in cardiogenic shock. Specifically, as a never-before-approved active ingredient, istaroxime may receive New Chemical Entity (NCE) designation from the FDA. If the new drug application is approved with such a designation, istaroxime would be entitled to 5 years of data exclusivity, and a stay of FDA approval of any generic application equal to 7.5 years from the date of istaroxime’s FDA approval should any generic company challenge the patents that Windtree has obtained or is pursuing and if Windtree files a patent infringement lawsuit in response to such a challenge.