This paper discusses the sources of harm that courts have accepted as being irreparable in prior decisions, including reductions in funds for research and development (R&D), loss of share to therapeutic competitors, loss of goodwill, and negative effects on employment and manufacturing facilities. Section 1 explains the initial effect of generic entry on revenues and sales volumes of the branded drug company. This discussion sets the stage for Section 2, which describes the irreparable harm that can ensue from lost sales, as well as other forms of irreparable harm that can arise from “at risk” generic entry. Section 3 discusses court decisions that have upheld plaintiffs’ claims for preliminary injunctions to prevent “at risk” generic entry, with a focus on how courts have responded to branded drug company claims of irreparable harm.

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