Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶9

The FDA must approve new and generic drugs before they go to market. See Caraco, 566 U. S., at 404–405. For approval to market a new drug, the manufacturer must submit a new drug application (NDA) with at least three types of supporting documents: (1) reports setting forth sufficient information to establish the drug’s safety and efficacy for its intended uses; (2) “the labeling proposed to be used for such drug”; and (3) the relevant drug patents, whether they protect the drug itself or the manufacturer’s exclusive rights over a particular “method of using such drug.” 21 U. S. C. §§355(b)(1)(A)(i), (vi), (viii); see Caraco, 566 U. S., at 404–405.

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