Gandhi Kajal, Joga Ramesh, Sowndharya M, Vijay Gadekar Kailas, Waiker Sonali, Yerram Sravani, Raghuvanshi Rajeev Singh, Srivastava Saurabh
Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, Hyderabad, 500037, Telangana, India.
Central Drug Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi, India.
Ther Innov Regul Sci. 2025 Jul 14. doi: 10.1007/s43441-025-00831-w.
This article aims to explore the implications of Paragraph IV certification on generic drug market entry while innovators' patents are still active. It also examines the challenges posed by patent settlements, the BLOCKING Act, and the FDA's decision-making process regarding generic applications. The objective is to shed light on the complexities of pharmaceutical market dynamics, regulatory practices, and the balance between innovation and accessibility.
The study involves a detailed analysis of the USFDA's recently published Para IV certification list and application statuses from 2020 to 2024. It reviews litigation trends among top generic manufacturers and scrutinizes the impact of patent disputes on market entry. The study also evaluates the potential effects of the BLOCKING Act on the 180-day exclusivity period and generic drug market dynamics.
The analysis reveals that nearly half of the ANDA applications submitted through Paragraph IV certification are deemed 'Eligible,' with significant portions either deferred or extinguished. A peak in eligible ANDA submissions was observed in 2023. Litigation trends show active patent challenges by leading generic companies like Teva, Apotex, and Actavis. The study highlights the FDA's role in facilitating first ANDA approvals, emphasizing the importance of providing safe and effective generic alternatives.
The study concludes that while the FDA supports generic companies in their application processes, patent litigation remains a significant hurdle, delaying the availability of cost-effective generic drugs. The BLOCKING Act, if enacted, is likely to disrupt the 180-day exclusivity incentive, reducing the predictability and value of generic drug market entry.
本文旨在探讨在创新者专利仍有效时，第IV段认证对仿制药市场进入的影响。它还研究了专利和解、《阻止法案》以及美国食品药品监督管理局（FDA）关于仿制药申请的决策过程所带来的挑战。目的是阐明制药市场动态、监管实践以及创新与可及性之间平衡的复杂性。
该研究对美国食品药品监督管理局最近公布的2020年至2024年第IV段认证清单和申请状态进行了详细分析。它回顾了顶级仿制药制造商之间的诉讼趋势，并审视了专利纠纷对市场进入的影响。该研究还评估了《阻止法案》对180天独占期和仿制药市场动态的潜在影响。
分析表明，通过第IV段认证提交的仿制药申请（ANDA）中，近一半被视为“合格”，其中很大一部分被推迟或终止。2023年观察到合格ANDA提交量达到峰值。诉讼趋势显示，梯瓦（Teva）、阿博泰克斯（Apotex）和阿特维斯（Actavis）等领先仿制药公司积极发起专利挑战。该研究强调了FDA在促进首个ANDA批准方面的作用，强调了提供安全有效的仿制药替代品的重要性。
该研究得出结论，虽然FDA在仿制药公司的申请过程中提供支持，但专利诉讼仍然是一个重大障碍，延迟了具有成本效益的仿制药的供应。如果《阻止法案》颁布，可能会扰乱180天独占期激励措施，降低仿制药市场进入的可预测性和价值。
