No Need To Fight: Teva Retains Provigil Generic Exclusivity Even Without “Adversarial” Relationship

U.S. Judge Ellen Segal Huvelle denies Mylan’s request to block the agency’s award of modafinil 180-day marketing rights to Teva. Mylan’s argument that the existence of an adversarial relationship between an ANDA first-filer and NDA holder is necessary for an award of generic marketing exclusivity is “fatally flawed,” the judge says, although she expresses sympathy for the plaintiff’s Hatch-Waxman policy arguments.