ANDA Filing Free-For-All? Matrix's Stay In Kaletra Case Could Remove Risks Of Submitting Early Dual Certification Generic Drug Applications
Executive Summary
Matrix's ability to win a stay of litigation over Kaletra patents - and thus avoid a potential forfeit of its generic exclusivity - suggests a possible strategy for other early ANDA filers
You may also be interested in...
Generics Industry Faces Five Major Challenges, Actavis CEO Says (We're Partly Responsible For One Of Them, He Acknowledges)
U.S. ANDA makers are ending their silver anniversary year on a glum note
Generics Industry Faces Five Major Challenges, Actavis CEO Says (We're Partly Responsible For One Of Them, He Acknowledges)
U.S. ANDA makers are ending their silver anniversary year on a glum note
Teva Gets Exclusivity For Generic Kytril; FDA Still Worries About Racing, Parking
In granting Teva 180-day marketing exclusivity for its generic formulation of Roche's antinausea drug Kytril (granisetron), FDA has laid out initial ground rules for determining when ANDA holders forfeit exclusivity