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An event study of the effect of the Drug Price Competition and Patent Term Restoration Act of 1984 on stock returns of research-based and generic pharmaceutical manufacturers.

机译:对1984年《药品价格竞争和专利期限恢复法》对研究型和非专利药制造商的股票收益产生影响的事件研究。

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摘要

The Drug Price Competition and Patent Term Restoration Act of 1984 (The Act) had two primary purposes: (1) increase incentives for research-based pharmaceutical manufacturers to develop pioneer drugs by providing a method to extend the time span of patent protection; and (2) reduce FDA regulatory requirements needed for premarket approval of generic versions of post-1962 off-patent drug products.;This study used an event study methodology to detect abnormal stock returns that may have occurred around events which led to the passage of The Act. Data were analyzed from: (a) a portfolio of twelve research-based pharmaceutical manufacturers; and (b) a portfolio of four generic pharmaceutical manufacturers. The ordinary least squares regression market model was used to detect abnormal returns utilizing dummy variables for each event day. This study also analyzed the stock market's reaction to a previous attempt to pass patent-term restoration legislation in 1981 and 1982.;The results indicate that there was enough uncertainty during the legislative history of The Act to keep the stock market from considering the impact of The Act on research-based and generic pharmaceutical manufacturers until August 1984. The results also provide strong evidence that when the probability of passage increased and the final form of the bill became more clear, the stock market expected The Act to negatively affect the financial performance of research-based pharmaceutical manufacturers. The market reacted positively to The Act with regard to generic pharmaceutical manufacturers although the small number of generic firms increased the relative contribution of each individual firm to the portfolio return. This may have made it more difficult to identify significant market reactions toward the generic drug industry.;It is recommended that similar event study methodologies be utilized to examine the effect of other events on research-based pharmaceutical manufacturers. Events which could be studied with this methodology include research and development announcements of breakthroughs in drug therapy, FDA approvals of new drug, and announcements of new competition from either generic drug products or new pioneer products within the same therapeutic class.
机译:1984年的《药品价格竞争和专利期限恢复法》(该法)有两个主要目的:(1)通过提供延长专利保护期限的方法,增加对研究型制药商开发先锋药的激励; (2)降低1962年后非专利产品仿制药的上市前批准所需的FDA监管要求。该研究使用事件研究方法来检测可能导致事件通过的事件周围发生的异常库存收益。法案。分析了以下数据:(a)由十二家研究型制药企业组成的投资组合; (b)四家仿制药生产商的投资组合。普通最小二乘回归市场模型用于利用每个事件日的虚拟变量来检测异常收益。这项研究还分析了股票市场对1981年和1982年通过专利期限恢复立法的先前尝试的反应;结果表明,该法案的立法历史上有足够的不确定性,可以防止股票市场考虑到该法针对研究型和非专利药制造商的法案到1984年8月为止。结果还提供了有力的证据,当通过的可能性增加并且法案的最终形式变得更加明确时,股票市场预计该法案将对财务业绩产生负面影响。研究型药品制造商。市场对仿制药生产商对该法做出了积极反应,尽管少数仿制药公司增加了每个公司对投资组合收益的相对贡献。这可能使识别仿制药行业的重大市场反应变得更加困难。;建议使用类似的事件研究方法来研究其他事件对研究型药物制造商的影响。可以使用这种方法进行研究的事件包括:药物治疗方面的突破性研究和开发公告,FDA对新药的批准以及同种疗法中非专利药产品或新先锋产品的新竞争声明。

著录项

  • 作者

    Proctor, Kurt Alan.;

  • 作者单位

    The University of Texas at Austin.;

  • 授予单位 The University of Texas at Austin.;
  • 学科 Economics Finance.;Health Sciences Pharmacy.;Political Science General.
  • 学位 Ph.D.
  • 年度 1989
  • 页码 176 p.
  • 总页数 176
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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