The Operation Dilemmas, Cause Analysis and Institutional Improvement of the Market Exclusivity Period System for First Generic Drugs in China

FENG Xiangyang; HUANG Lu; LIU Yangyang

doi:10.16522/j.cnki.cjph.2025.07.017

Chinese Journal of Pharmaceuticals, Volume. 56, Issue 7, 965(2025)

The Operation Dilemmas, Cause Analysis and Institutional Improvement of the Market Exclusivity Period System for First Generic Drugs in China

FENG Xiangyang^1,2, HUANG Lu^3,4,5,6, and LIU Yangyang⁷

Author Affiliations

¹Civil, Commercial and Economic Law School, China University of Political Science and Law, Beijing 100088

²BrightGene Bio-Medical Technology Co., Ltd., Suzhou 215123

³School of Pharmacutical Sciences, Wuhan University, Wuhan 430071

⁴School of Chemical Engineering and Pharmacy, Wuhan Institute of Technology, Wuhan 430205

⁵School of Law, Humanities and Society, Wuhan University of Technology, Wuhan 430070

⁶Law and Business School of Wuhan Instiute of Technology (School of Intellectual Property), Wuhan 430205

⁷Coherent Biopharma (suzhou) Co., Ltd., Suzhou 215123

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References(2)

[7] [7] LAWRANCE S, BOND E. ‘Reverse-payment’ patent settlement agreements: non-cash value transfers are not immune from competition law scrutiny [J].J Intellectual Property Law Practice, 2018,13(7): 552-554.

[8] [8] FDA. Marketing of first generic drugs approved by U. S. FDA from January 2010 to June 2017 [EB/OL]. (2021-11-15) [2024-12-9]. https://www.fda.gov/media/154101/download.

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FENG Xiangyang, HUANG Lu, LIU Yangyang. The Operation Dilemmas, Cause Analysis and Institutional Improvement of the Market Exclusivity Period System for First Generic Drugs in China[J]. Chinese Journal of Pharmaceuticals, 2025, 56(7): 965

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Paper Information

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Received: Feb. 17, 2025

Accepted: Aug. 26, 2025

Published Online: Aug. 26, 2025

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DOI:10.16522/j.cnki.cjph.2025.07.017

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