Mylan Faces Skeptical Judge In Bid To Undo Teva Provigil Generic Exclusivity
This article was originally published in The Pink Sheet Daily
Executive Summary
During more than two-and-a-half hours of oral arguments, Judge Ellen Huvelle repeatedly asked Mylan’s counsel how the Hatch-Waxman Act gives her the power to order FDA to take modafinil 180-day exclusivity rights away from Teva. However, the judge also expressed “deep concern” that Teva would challenge FDA’s trigger decision and further delay other ANDA filers from coming to market.