美国制药行业的横向持股和第四款通用进入

Q2 Social Sciences
Jin Xie
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引用次数: 1

摘要

联邦贸易委员会经常对名牌制药公司和仿制药制造商之间的“延迟付款”和解提出投诉,后者挑战受专利保护药物的垄断地位。我记录的是,当前20名普通股股东在该品牌中拥有更大的经济利益时,该品牌与第一家普通股达成和解协议以挑战该品牌的可能性就会增加。这种和解的结果是从品牌向仿制药付款,以换取仿制药的延迟进入。只有在第一个仿制药进入后,该特定仿制药的180天营销独占期才开始。其他仿制药只能在该期限到期后才能上市。因此,品牌和第一个通用之间的和解扩大了品牌的垄断地位。我的结论是,横向持股有助于品牌专利持有人和仿制药挑战者之间的协调,以应对进入的威胁。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Horizontal Shareholdings and Paragraph IV Generic Entry in the U.S. Pharmaceutical Industry
The Federal Trade Commission frequently files complaints against “pay-for-delay” settlements between brand-name pharmaceutical companies and generic-drug manufacturers, the latter of which challenge the monopoly status of patent-protected drugs. I document than when the top 20 generic shareholders have more substantial financial interests in the brand, then the likelihood that the brand enters into a settlement agreement with the first generic to challenge the brand goes up. The result of such a settlement is a payment from brand to generic, in exchange for the generic’s delayed entry. Only after the first generic’s entry, a 180-day period of marketing exclusivity for that particular generic starts. Other generics can only market their drugs after that period expires. As such, the settlement between brand and the first generic extends the brand’s monopoly position. I conclude that horizontal shareholdings facilitate coordination between brand-name patent holders and generic challengers in response to the threat of entry.
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来源期刊
Antitrust Bulletin
Antitrust Bulletin Social Sciences-Law
CiteScore
1.30
自引率
0.00%
发文量
34
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