2007年FDAAA (Food and Drug Administration Amendments Act) 通过后，法律要求原研药公司报告授权仿制药的上市情况，也要求FDA建立授权仿制药的数据库。各原研公司会在每年的年报中报告自家的授权仿制药上市情况，而FDA的数据库每季度更新一次。2018年3月份最新公布的这份授权仿制药清单 【截至2018年3月28日的授权仿制药清单】中，需要报告授权仿制药的通用名、剂型、规格、NDA持有人名称、上市时间和退市时间。
3 Zain S. Sword or Shield-An Overview and Competitive Analysis of the Marketing of Authorized Generics[J]. Food & Drug LJ, 2007, 62: 739. url
4 Understahl B. Authorized generics: careful balance undone[J]. Fordham Intell. Prop. Media & Ent. LJ, 2005, 16: 355.url
5 Chen, Tom, Authorized Generics: A Prescription for Hatch-Waxman Reform. Virginia Law Review, Vol. 93, p. 459, 2007. Available at SSRN: url
6 Berndt E R, Mortimer R, Bhattacharjya A, et al. Authorized generic drugs, price competition, and consumers’ welfare[J]. Health Affairs, 2007, 26(3): 790-799. url
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Mandatory Reading:
Regulatory Affairs (Reg)
Intellectual Property (IP)
Quality Assurance (QA)
Legal Department
Work Suggestions:
Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
IP: Monitor patent term extensions and the impact on the company's patent strategy.
QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.
Scope of Application: The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.
Key Points Summary:
Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.
Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.
Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.
Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.
Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.
Conclusion: The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.
】中，需要报告授权仿制药的通用名、剂型、规格、NDA持有人名称、上市时间和退市时间。