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When Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the "Hatch-Waxman Act," it sought, in part, to expedite the approval of generic drugs by the U.S. Food and Drug Administration (FDA). In order for a generic drug manufacturer to obtain such expedited approval under Hatch-Waxman, the manufacturer must show that: (1) the proposed generic drug is the chemical equivalent of an approved branded-drug; (2) the proposed generic is "bioequivalent" to an approved branded-drug; and (3) the proposed labeling for the generic drug is the same as the labeling for an approved branded-drug. See 21 U.S.C. §355(j)(2)(A)(ii)-(v) (2013). While Hatch-Waxman has successfully brought thousands of generic drugs to the market at a much swifter rate than its branded equivalents, it has not done so without some legal pitfalls.

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