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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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