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Musical Tables in Generic Drug Litigation

This article was originally published in RPM Report

Executive Summary

Generic drug litigation remains a prominent part of food and drug law practices. But with the growing complexity of the case law—and the blurring lines within industry—it is very hard to predict which client and which attorney will be on what side. Back-to-back hearings on Provigil and Vancocin make that clear.

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

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ViroPharma’s Failed Exclusivity Bid For Vancocin Could Spur Congress To Act

FDA’s decision that vancomycin oral capsules do not qualify for Hatch-Waxman marketing protection under a 2008 law could become the focus of a legislative “fix” in pending user fee bills if lawmakers disagree with the agency’s conclusion that only approval of a “significant new use” for older antibiotics warrants exclusivity.

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.

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