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.
You may also be interested in...
Provigil Generic Exclusivity Decision “Eviscerates” Hatch-Waxman, FTC Says
In a strongly worded amicus brief filed in Mylan’s lawsuit against FDA, the Federal Trade Commission says it would have required different remedies in clearing Teva’s acquisition of Cephalon last year had it known the Israel-based firm would receive sole 180-day marketing exclusivity for modafinil.
Provigil Generic Exclusivity Dispute Keeps Lawyers Up At Night
Teva dropped its suit when FDA conceded the firm has 180-day marketing exclusivity for generic Provigil; Mylan then sued the agency claiming Teva lost its exclusivity rights with its acquisition of Cephalon.
Cephalon Loses Market Exclusivity On Provigil To Its Own Parent Company
Teva’s March 30 authorized generic launch appears to give it a jump over other modafinil ANDA holders, who had settled patent litigation with Cephalon and were expected to enter the market in April. Several companies are expected to share 180-day marketing exclusivity rights for modafinil, although the fate of Ranbaxy’s ANDA under a recently negotiated FDA consent decree remains unclear.