Exclusivity
This article was originally published in The Tan Sheet
Executive Summary
FDA requests comments on whether pediatric exclusivity runs concurrently or consecutively with 180-day generic exclusivity "when a favorable court decision in a paragraph IV patent challenge lawsuit is issued less than 180 days before the beginning of or during the pediatric exclusivity period." In Federal Register notice slated for publication May 21, agency says it has received inquiries from "pharmaceutical firms, organizations, individuals and members of Congress" regarding FDA's interpretation of exclusivity provisions, although, "to date, there has not been a situation where pediatric exclusivity and 180-day generic exclusivity have actually overlapped." Comments are due in 30 days