解锁通用市场准入:对美国FDA第IV段文件 (2020-2024) 的回顾性分析
Kajal Gandhi1, Ramesh Joga1, M Sowndharya1
1Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, Hyderabad, 500037, Telangana, India.
Therapeutic innovation & regulatory science
|July 14, 2025
概括
第IV条认证允许仿制药进入市场,但专利诉讼和潜在的BLOCKING Act变更造成了重大障碍. 这些因素推迟了负担得起的仿制药获取,影响了市场动态和患者的可访问性.
科学领域:
- 制药经济学 制药经济学
- 监管科学是一种监管科学.
- 知识产权法 知识产权法
背景情况:
- 第四部分 (PIV) 认证允许在专利到期之前申请仿制药.
- 创新者专利和专利和解显著影响通用产品进入市场的时间表.
- 监管框架,包括FDA的流程和像BLOCKING法案这样的拟议立法,塑造了制药市场的动态.
研究的目的:
- 分析PIV认证对仿制药市场进入的影响.
- 审查来自专利和解,BLOCKING法案和FDA决定的挑战.
- 了解制药创新和药物可获得性之间的平衡.
主要方法:
- 对USFDA PIV认证清单和申请状态 (2020-2024) 的分析.
- 审查主要仿制药制造商之间的诉讼趋势.
- 对"封锁法"对独家权期的潜在影响的评估.
主要成果:
- 近50%的PIV ANDA申请是"有资格"的,而其他申请则被推迟或被灭.
- 在2023年,符合条件的ANDA提交量达到峰值.
- 领先的仿制药公司积极挑战专利,但诉讼延迟了市场进入.
结论:
- 专利诉讼仍然是及时提供仿制药的主要障碍.
- 拟议的BLOCKING法案可能会减少180天独家权的激励,降低进入市场的可预测性.
- 美国食品和药物管理局 (FDA) 促进了仿制药的应用,但法律挑战对具有成本效益的药物获取产生了重大影响.
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