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Generic Success In Patent Cases May Slow Momentum For Waxman/Hatch Fix

Executive Summary

A string of recent patent victories for the generic industry may take some momentum away from the drive for Waxman/Hatch reform

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Teva’s Generic Remeron Exclusivity Cut To Five Months By FDA Rules

Teva's generic Remeron (mirtazapine) will have only five months of marketing exclusivity from its approval date due to FDA's current interpretation of the trigger for first-to-file 180-day marketing exclusivity under the Waxman/Hatch Act, Teva reported in its Feb. 18 earnings teleconference

Teva’s Generic Remeron Exclusivity Cut To Five Months By FDA Rules

Teva's generic Remeron (mirtazapine) will have only five months of marketing exclusivity from its approval date due to FDA's current interpretation of the trigger for first-to-file 180-day marketing exclusivity under the Waxman/Hatch Act, Teva reported in its Feb. 18 earnings teleconference

Naprelan Generic Exclusivity Settled; Andrx Sees Three Near-Term Launches

SkyePharma has waived its 180-day exclusivity for a generic version of Elan's Naprelan (naproxen), clearing the way for approval of Andrx' generic version of the product, Andrx says

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