Faculty of Law, University of Cambridge, The Sir David Williams Building, 10 West Road, Cambridge, CB3 9DZ, UK.
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Pharmaceut Med. 2024 Jul;38(4):303-310. doi: 10.1007/s40290-024-00527-w. Epub 2024 Jul 14.
Originator drug manufacturers use several strategies to delay generic competition in the USA, but it remains unclear whether this results in longer market exclusivity compared to other countries.
We sought to understand how drug market exclusivity lengths vary between the USA and two comparable countries.
We focused on drugs approved within 2 years of each other in the USA, France, and Australia from 1995 to 2005, and we compared the lengths of exclusivity from marketing approval through first generic competition or June 2023 using Kaplan-Meier analyses.
Among 165 drugs in common between the USA and France, the median length of exclusivity was slightly longer in France (15.0 years, interquartile range [IQR]: 13.0-19.6) than the USA (14.5 years, IQR: 11.7-17.6). Among 100 drugs in common between the USA and Australia, the median length of exclusivity was longer in Australia (16.3 years, IQR: 13.9-22.4) than in the USA (14.4 years, IQR: 12.0-17.1).
Market exclusivity lengths in the USA are not longer than in France and Australia. Potential reasons include the larger US market and incentives that offer transient high generic drug prices in the USA for manufacturers that successfully challenge originator market exclusivity.
原创药制造商在美国采用了多种策略来延迟仿制药竞争，但目前尚不清楚这是否会导致与其他国家相比，市场独占期更长。
我们旨在了解美国与两个可比国家之间的药物市场独占期长度有何不同。
我们专注于 1995 年至 2005 年间在美国、法国和澳大利亚同期批准的药物，使用 Kaplan-Meier 分析比较从市场批准到首次仿制药竞争或 2023 年 6 月的独占期长度。
在 165 种美国和法国共同的药物中，法国的独占期中位数略长（15.0 年，四分位距 [IQR]：13.0-19.6），而美国为 14.5 年（IQR：11.7-17.6）。在 100 种美国和澳大利亚共同的药物中，澳大利亚的独占期中位数较长（16.3 年，IQR：13.9-22.4），而美国为 14.4 年（IQR：12.0-17.1）。
美国的市场独占期长度并不长于法国和澳大利亚。潜在原因包括美国市场规模较大，以及对于成功挑战原创药市场独占期的制造商在美国提供的暂时高仿制药价格激励。
