中国新药杂志

专利到期对药品价格和市场份额的影响分析

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柏林 ¹ , 张逸晨 ¹ , 范平安 ¹ , 史录文 ¹^,² , 陈敬 ¹^,²

中国新药杂志 | 新药述评与论坛 2021,30(6): 481-488

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中国新药杂志 |新药述评与论坛 2021 , 30 (6) : 481 -488

专利到期对药品价格和市场份额的影响分析

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柏林¹, 张逸晨¹, 范平安¹, 史录文¹^,², 陈敬¹^,²

作者信息

¹北京大学药学院药事管理与临床药学系，北京　100191

²北京大学医药管理国际研究中心，北京　100191

通讯作者:

陈敬，女，博士，讲师，研究方向：医药政策与法律。联系电话：（010）82801701，E-mail：jingchen@bjmu.edu.cn。

作者简介:

柏林，女，硕士研究生，研究方向：药事管理。E-mail：bailin@pku.edu.cn。

Analysis of the impact of patent expiry on drug price and market share

Lin BAI¹, Yi-chen ZHANG¹, Ping-an FAN¹, Lu-wen SHI¹^,², Jing CHEN¹^,²

Affiliations

¹Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China

²International Research Center for Medicinal Administration, Peking University, Beijing 100191, China

出版时间: 2021-03-30

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摘要

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目的：

系统评估国内外药品专利到期后价格及市场份额的变化，为促进我国创新药与仿制药的平衡发展提供循证参考。

方法：

计算机检索PubMed，Scopus，The Cochrane Library，CNKI，WanFang Data和VIP数据库，搜索与专利到期或专利过期对原研药或仿制药价格及市场份额影响有关的研究，检索时限为建库至2019年9月30日。由2名研究人员独立筛选文献和提取资料后，采取定性分析的方法评价专利到期对药品价格和市场份额的影响结果。

结果：

共纳入26篇文献，10篇涉及专利到期后药品价格和市场份额的变化，14篇只涉及专利到期后药品价格的变化，2篇只涉及市场份额的变化。结果显示，专利到期1~8年后，仿制药市场份额增大到56%~92%。在专利到期或首仿药上市后的第1~10年中，药品整体价格下降到专利到期前原研药价格的20%~98%，但原研药具有一定的价格刚性，价格变动幅度均在25%以内，且部分药品出现“仿制药竞争悖论”现象。

结论：

专利到期后药品整体价格下降，原研药表现出一定的价格刚性。仿制药市场份额随时间呈上升趋势，参与竞争的仿制药厂商数量、价格折扣、现行的仿制药政策等均对仿制药替代速度产生影响。

关键词

专利到期 / 药品价格 / 市场份额 / 仿制药 / 原研药

Abstract

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Objective:

To systematically review the impact of patent expiry on drug price and market share, and provide evidence-based reference for promoting the balanced development of innovative drugs and generic drugs in China.

Methods:

PubMed, Scopus, the Cochrane Library, CNKI, WanFang Data and VIP databases were searched to identify studies on the impact of patent expiration on the prices and market shares of original or generic drugs from inception to September 31, 2019. After relevance screening and data extraction, a standardized assessment was performed by two independent reviewers. Then, qualitative analysis was applied to evaluate the impact of patent expiration on the prices and market shares of original or generic drugs.

Results:

A total of 26 literatures were included, 10 of which were related to changes in drug prices and market shares after the expiration of patents, 14 related to changes in drug prices, and 2 related to changes in market shares. The identified studies indicated that the market shares of generic drugs ranged from 56% to 92% 1~8 years after patent expiry, and drug prices decreased to 20%~98% of the brand drug price 1~10 years after patent expiry. The prices of original prices were rigid and varied within 25%, while some even increased after generic drugs' entry.

Conclusion:

After the expiration of patent, the overall drug prices decrease, and the original drugs show a certain price rigidity. The market share of generic drugs is increasing over time. The number of generic competitors, price discounts, and current generic drug policies could have an impact on the speed of generic substitution.

Key words

patent expiry / drug price / market share / generic drug / original drug

引用本文

柏林, 张逸晨, 范平安, 史录文, 陈敬. 专利到期对药品价格和市场份额的影响分析. 中国新药杂志, 2021 , 30 (6) : 481 -488 .

Lin BAI, Yi-chen ZHANG, Ping-an FAN, Lu-wen SHI, Jing CHEN. Analysis of the impact of patent expiry on drug price and market share[J]. Chinese Journal of New Drugs, 2021 , 30 (6) : 481 -488 .

基金

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国家自然科学基金面上项目(71874006)
基于仿制药与原研药选择视角的医生处方行为影响因素与准实验干预研究

参考文献

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文献

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参考文献引证文献

排序方式：

[1]

GRABOWSKI H, VERNON J. Longer patents for increased generic competition in the US. The Waxman-Hatch Act after one decade[J]. Pharmacoeconomics, 1996, 10(Suppl 2): S110-S123.

[2]

SUH DC, MANNING WG, JR., SCHONDELMEYER S, et al. Effect of multiple-source entry on price competition after patent expiration in the pharmaceutical industry[J]. Health Serv Res, 2000, 35(2): 529-547.

[3]

LEXCHIN J. The effect of generic competition on the price of brand-name drugs[J]. Health Policy, 2004, 68(1): 47-54.

[4]

MAGAZZINI L, PAMMOLLI F, RICCABONI M. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure[J]. Eur J Health Econ, 2004, 5(2): 175-182.

[5]

WIGGINS STEVEN N, ROBERT M. Price Competition in pharmaceuticals: the case of anti-infectives[J]. Econ Inq, 2004, 42(2): 247-263.

[6]

DRUSS BG, MARCUS SC, OLFSON M, et al. Listening to generic Prozac: winners, losers, and sideliners[J]. Health Aff (Millwood), 2004, 23(5): 210-216.

[7]

BOERSMA C, KLOK RM, BOS JM, et al. Drug costs developments after patent expiry of enalapril, fluoxetine and ranitidine: a study conducted for the Netherlands[J]. Appl Health Econ Health Policy, 2005, 4(3): 191-196.

[8]

HONG SH, SHEPHERD MD, SCOONES D, et al. Product-line extensions and pricing strategies of brand-name drugs facing patent expiration[J]. J Manag Care Pharm, 2005, 11(9): 746-754.

[9]

SAHA ATANU, GRABOWSKI HENRY, BIRNBAUM HOWARD, et al. Generic Competition in the US Pharmaceutical Industry[J]. Intern J Econ Bus, 2006, 13(1): 15-38.

[10]

LAKDAWALLA D, PHILIPSON T, WANG R. Intellectual property and marketing[EB/OL]. [2008-02-04]. https://ssrn.com/abstract=1089045.

[11]

BERNDT ER, MORTIMER R, BHATTACHARJYA A, et al. Authorized generic drugs, price competition, and consumers' welfare[J]. Health Aff (Millwood), 2007, 26(3): 790-799.

[12]

GRABOWSKI HENRY G, RIDLEY DAVID B, SCHULMAN KEVIN A. Entry and competition in generic biologics[J]. Manag Decis Econ, 2007, 28(4-5): 439-451.

[13]

KANAVOS P, COSTA-FONT J, SEELEY E. Competition in off-patent drug markets-issues, regulation and evidence[J]. Econ Polioy, 2008, 23(55): 500-544.

[14]

CLARKE PM, FITZGERALD EM. Expiry of patent protection on statins: Effects on pharmaceutical expenditure in Australia[J]. Med J Austr, 2010, 192(11): 633-636.

[15]

BERNDT ER, AITKEN ML. Brand Loyalty, Generic entry and price competition in pharmaceuticals in the quarter century after the 1984 Waxman-Hatch legislation[J]. Int J Econ Business, 2011, 18(2): 177-201.

[16]

PUIG-JUNOY J. Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?[J]. Appl Health Econ Health Policy, 2012, 10(6): 441-451.

[17]

SOTIRIS V, PANOS K. The generics paradox revisited: empirical evidence from regulated markets[J]. Appl Econ, 2013, 45(22): 3230-3239.

[18]

KELTON CM, CHANG LV, GUO JJ, et al. Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008[J]. Appl Health Econ Health Policy, 2014, 12(2): 165-177.

[19]

KANAVOS P. Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States[J]. Health Policy, 2014, 118(2): 229-241.

[20]

GRABOWSKI H, LONG G, MORTIMER R, et al. Updated trends in US brand-name and generic drug competition[J]. J Med Econ, 2016, 19(9): 836-844.

[21]

BALKHI B, SEOANE-VAZQUEZ E, RODRIGUEZ-MONGUIO R. OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES: GENERIC COMPETITION, PRICING STRUCTURE, AND DISPERSION AMONG PAYERS[J]. Int J Technol Assess Health Care, 2016, 32(6): 385-392.

[22]

FISCHER KE, STARGARDT T. The diffusion of generics after patent expiry in Germany[J]. Eur J Health Econ, 2016, 17(8): 1027-1040.

[23]

CHENG N, BANERJEE T, QIAN J, et al. Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011[J]. J Am Pharm Assoc (2003), 2017, 57(3): 341-348.

[24]

LAKDAWALLA D, MACEWAN JP, DUBOIS R, et al. What do pharmaceuticals really cost in the long run?[J]. Am J Manag Care, 2017, 23(8): 488-493.

[25]

WOUTERS OJ, KANAVOS PG, MC KEE M. Comparing generic drug markets in Europe and the United States: prices, volumes, and spending[J]. Milbank Q, 2017, 95(3): 554-601.

[26]

ROUGHEAD EE, KIM DS, ONG B, et al. Pricing policies for generic medicines in Australia, New Zealand, the Republic of Korea and Singapore: patent expiry and influence on atorvastatin price[J]. WHO South East Asia J Public Health, 2018, 7(2): 99-106.

2021年第30卷第6期

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首发时间：2026-10-29
出版时间：2021-03-30

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录用日期：2020-04-04

基金

国家自然科学基金面上项目(71874006)

基于仿制药与原研药选择视角的医生处方行为影响因素与准实验干预研究

作者信息

¹北京大学药学院药事管理与临床药学系，北京　100191

²北京大学医药管理国际研究中心，北京　100191

通讯作者:

陈敬，女，博士，讲师，研究方向：医药政策与法律。联系电话：（010）82801701，E-mail：jingchen@bjmu.edu.cn。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
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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