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Advances in generic drug approval process and challenges in the U.S. after Hatch-Waxman Act
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Yun-peng PENG, Yi-hua XU
Chinese Journal of New Drugs | 2023, 32(10) : 977 - 984
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Chinese Journal of New Drugs | 2023, 32(10): 977-984
Advances in generic drug approval process and challenges in the U.S. after Hatch-Waxman Act
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Yun-peng PENG, Yi-hua XU
Affiliations
  • Faculty of Law, Macau University of Science and Technology, Macao 999078, China
Published: 2023-05-30
Outline
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It has been nearly 40 years since the Hatch-Waxman Act was enacted in 1984. Generics have developed tremendously during this period, which shows the importance of promoting the development of generics. The Hatch-Waxman Act is important, but it is not the whole story of how generics develop in the United States. After the promulgate of Hatch-Waxman Act, the development mechanism of generic drugs in the United States did not stick to the original state, but continuously made dynamic adjustments in many aspects, including combating misconduct in abbreviated new drug application (ANDA) to standardize the procedures, greatly improving the time efficiency for ANDA, establishing a generic drug replacement mechanism, establishing two patent invalidation procedures [inter parte review (IPR) and post grant review (PGR)], revising the Orange Book, exclusivity period, containment period, etc. to improve patent links system, and establishing a drug price negotiation system and a drug inflation penalty system. China should shorten the period of drug patent reexamination and invalidation examination. The first generic drug exclusivity period system should be coordinated with anti-monopoly. A user payment system should be established in China, but innovative drugs can be exempted. The drug approval and review mechanism, patent law, anti-monopoly law and other fields need to work together to continuously track and improve relevant systems.

Hatch-Waxman Act  /  generics  /  patent linkage
Yun-peng PENG, Yi-hua XU. Advances in generic drug approval process and challenges in the U.S. after Hatch-Waxman Act[J]. Chinese Journal of New Drugs, 2023 , 32 (10) : 977 -984 .
Year 2023 volume 32 Issue 10
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  • Online Date:2026-03-05
  • Published:2023-05-30
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  • Accepted:2022-11-17
Affiliations
    Faculty of Law, Macau University of Science and Technology, Macao 999078, China
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表12种不同金属材料的力学参数

Family
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Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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