| 来源类型 | Working Paper |
| 规范类型 | 报告 |
| DOI | 10.3386/w29131 |
| 来源ID | Working Paper 29131 |
| No Free Launch: At-Risk Entry by Generic Drug Firms | |
| Keith M. Drake; Robert He; Thomas McGuire; Alice K. Ndikumana | |
| 发表日期 | 2021-08-09 |
| 出版年 | 2021 |
| 语种 | 英语 |
| 摘要 | After receiving FDA approval, a generic drug manufacturer can launch “at risk” before conclusion of any patent infringement litigation, but it risks paying damages if it loses. The generic can eliminate the risk by waiting to launch until the appeals process is complete but waiting has downsides too. We develop a model that implies that, after the generic has won a district court decision, at-risk entry is generally profitable and will occur quickly unless the cost of waiting for the appeal is very low. We examine generic drug applications that have received FDA approval with “first-filer” status (which precludes later filing generics from entering before the first filer). In our data, the generic and brand usually settled prior to the conclusion of litigation. 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). We also consider implications of at-risk entry for social welfare, arguing that at-risk entry is analogous to a “buy out” of the patent with favorable welfare implications in both the short run (consumer prices) and long run (efficient incentives for R&D). |
| 主题 | Microeconomics ; Households and Firms ; Health, Education, and Welfare ; Health ; Development and Growth ; Innovation and R& ; D |
| URL | https://www.nber.org/papers/w29131 |
| 来源智库 | National Bureau of Economic Research (United States) |
| 引用统计 | |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/586805 |
| 推荐引用方式 GB/T 7714 | Keith M. Drake,Robert He,Thomas McGuire,et al. No Free Launch: At-Risk Entry by Generic Drug Firms. 2021. |
| 条目包含的文件 | ||||||
| 文件名称/大小 | 资源类型 | 版本类型 | 开放类型 | 使用许可 | ||
| w29131.pdf（335KB） | 智库出版物 | 限制开放 | CC BY-NC-SA | 浏览 | ||
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