Keith M. Drake, Robert He, Thomas G. McGuire, Alice Ndikumana
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引用次数: 0
Abstract
After receiving FDA approval, a generic drug manufacturer can launch ‘at risk’ before any patent infringement litigation concludes, but it risks paying damages if it ultimately loses the litigation. A generic can eliminate the risk by waiting to launch until after the appeals process is complete but waiting has downsides too. We examine FDA approvals of generic drug applications with ‘first-filer’ status (which precludes other generics from entering beforehand) to examine empirical patterns of at-risk entry. In our data, litigants usually settled prior to a legal decision. For the remainder, drugs that received FDA approval prior to a favorable district court decision were always launched at risk. Generics without FDA approval before a favorable district court decision launched upon approval unless the approval was close in time to the appeal decision, or it had forfeited the first-filer exclusivity (indicating a low cost of waiting).
期刊介绍：
International Journal of the Economics of Business presents original, peer reviewed research in economics that is clearly applicable to business or related public policy problems or issues. The term "business" is used in its widest sense to encompass both public and private sector—governmental, private non-profit and cooperative organizations, as well as profit-seeking enterprises. International Journal of the Economics of Business carries papers relating to three main spheres: The organization—to analyse and aid decision making and the internal organization of the business; The industry—to analyse how businesses interact and evolve within and across industries.
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