Reportlinker Adds Japan Pharmaceutical Market Overview Regulatory reforms will stimulate generics uptake

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Japan Pharmaceutical Market Overview Regulatory reforms will stimulate generics uptake

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Introduction

The pharmaceutical market in Japan was valued at $69.4 billion in 2009. Key growth drivers for branded pharma include the growing use of chronic high-value innovative treatments driven by an increasingly elderly population, the high proportion of the healthcare budget spent on pharmaceuticals compared to other developed pharmaceutical markets, and the low level of generic penetration.

Scope

*Overview of socioeconomic and demographic trends, healthcare system, regulation, pricing, reimbursement and intellectual property position in Japan

*Assesses the size of Japan's pharmaceutical market by prescribing setting, therapy area, leading brands and by leading companies

*Examines Japan's generics and biosimilars landscape in terms of regulatory issues, level of penetration, key players and degree of brand erosion

*Quantifies Japan's R&D and manufacturing infrastructure for the leading pharmaceutical companies, including key metrics and domestic M&A analysis

Highlights

Korosho determines the reimbursable drug price in Japan which is added to the National Health Insurance (NHI) list which must be followed by all insurers. The few non-reimbursed prescription drug groups include oral contraceptives, lifestyle drugs, and some vaccines.

Korosho implemented guidance for biosimilars approval in March 2009 and since then two biosimilars have been launched in Japan. Although this is a positive step for the biosimilars industry, the conservative and brand-loyal nature in Japan means that uptake will be slow, with only the larger, more well known players likely to succeed.

In contrast to the bleak prospects pervading the other major markets, Japan seems to have a brighter outlook with pharma companies having been less affected by job cuts and site closures.

Reasons to Purchase

*Evaluate the evolving regulatory landscape and the impact of pricing and reimbursement controls on market access in Japan.

*Quantify the size and growth of the prescription pharmaceutical market in Japan, analyzing key therapy areas, brands and companies.

*Assess drivers and resistors of generic and biosimilars uptake in Japan as well as the level of erosion brands can expect to face post patent expiry.

ABOUT DATAMONITOR HEALTHCARE 2

About the Healthcare Strategic Analysis Team 2

Geographic specific reports: 2

Global issue reports: 2

1. Japan - Executive Summary 3

Strategic scoping and focus 3

Key findings - healthcare drivers and resistors in Japan 4

Key findings - healthcare drivers and resistors in Japan 4

Japan - Socio-demographic and economic analysis 7

Socio-demographic trends 7

Socioeconomic trends 8

Japan - Healthcare system and drug regulatory analysis 9

Japan healthcare expenditure 9

Japan regulatory issues 10

Japan pricing and reimbursement issues 11

Japan - Prescription pharmaceutical sales analysis 13

Pharmaceutical market size 13

Leading therapy areas 13

Leading prescription pharmaceutical brands 13

Leading pharmaceutical companies 13

Japan - Drug expiry analysis 15

Japan generics market 15

Japan brand erosion post patent expiry 15

Japan biosimilars market 15

Japan - Pharmaceutical Industry Infrastructure analysis 17

Pharmaceutical industry infrastructure overview 17

Related reports 19

Upcoming related reports 19

TABLE OF CONTENTS 20

2. Japan - Socio-demographic and economic analysis 21

Key findings 21

Socio-demographic trends 21

Socioeconomic trends 21

Demographic trends in Japan 22

Japan's population is declining leading to a potential demographic crisis 23

Birth rate in Japan is the lowest in all major markets 25

Proportion of elderly individuals and life expectancy 26

Disease burden in Japan 28

Cerebrovascular disease is the leading cause of death in Japan 28

Non-communicable diseases are the main cause of overall disease burden in Japan 30

Political climate in Japan 31

Recent election resulted in a change of ruling political party 31

Japan is the second largest economy in the world but is on a verge of a fiscal crisis 32

Japan's budget deficit is projected to reach almost 10% of GDP in 2010 33

Business environment in Japan 35

Corporate income tax is high in Japan but is offset by a low personal income tax 35

There is little inward foreign direct investment in Japan 35

The unemployment rate in Japan is lower than in Western markets but rose during the recession 36

3. Japan - Healthcare system and drug regulatory analysis 37

Key findings 37

Japan healthcare expenditure 37

Japan regulatory issues 37

Japan pricing and reimbursement issues 37

Healthcare expenditure 39

Japan has a lower than OECD average healthcare spend per capita, but higher pharmaceutical spend 39

Health insurance system in Japan 42

The public health insurance system dominates healthcare provision in Japan 42

A range of government and non-government stakeholders exist in Japan 44

Provider fees are dictated by the government 46

Private health insurance in Japan focuses on covering out-of-pocket costs 47

Primary care versus hospital care in Japan - hospitals are the main destination for patients seeking healthcare 47

Hospital provision is weighted towards outpatient care 47

Japan has a high number of hospitals but low number of physicians 49

Several problems have been highlighted in the Japanese healthcare system 49

The Japanese healthcare system lacks cost-containment measures while the quality of care could be improved 50

Healthcare reforms in Japan focus on healthcare provision for the elderly 51

Aging population necessitates more stringent cost-containment measures 51

Since 2008 the elderly are covered by 2 types of insurance depending on age 52

Regulatory issues in Japan 53

The MHLW and the PMDA are the national drugs regulatory bodies in Japan 53

The application process in Japan consists of several stages 54

Certain drug categories can circumvent the ordinary review procedures 55

Requirements for manufacturing and clinical trials in Japan have relaxed although those for post-marketing requirements have increased 55

Drugs typically launch in Japan 3-4 years after launch in the EU and US 56

The PMDA has made efforts to reduce the drug lag-time 56

Intellectual property - patents are valid for 20 years from date of application in Japan 57

Revisions to the patent term extensions are both good and bad for the pharmaceutical industry 57

Revised patient examination guidelines for medical interventions broaden Scope of patentable subject matter 58

Japan permits generic manufacturers to perform work using patented technology 58

Japan gives branded pharma companies 8 years of data exclusivity through re-evaluation requirement 58

Drug counterfeiting in Japan 59

Pricing and reimbursement in Japan 60

A number of healthcare stakeholders impact government P&R strategy and healthcare provision 60

The DPO and Chuikyo are the key governmental stakeholders shaping P&R 60

The influence of healthcare stakeholders in shaping healthcare reform and P&R implementation is varied 61

Pricing and reimbursement are closely connected in Japan 61

The process of gaining a price and reimbursement level in Japan 61

Drug pricing largely depends on the level of innovation 63

A wide range of premiums are available for innovative drugs 65

The level of innovation required for premiums is difficult to attain 67

Recent changes to reference pricing will bring down launch prices 67

Cost containment in Japan revolves mainly around biennial price cuts 67

Prices of drugs were cut by an average of 5.75% in April 2010 69

Health reforms focus on cutting the country's drugs bill 71

Other pricing and reimbursement issues 72

Prescribing and dispensing have traditionally been linked in Japan 72

Out-of-pocket costs are high in Japan 73

Pharmacoeconomic analysis plays a role in Japan but on an informal basis 73

4. Japan - Prescription pharmaceutical sales analysis 74

Key findings 74

Pharmaceutical market size 74

Leading therapy areas 74

Leading prescription pharmaceutical brands 74

Leading pharmaceutical companies 74

Pharmaceutical market size in Japan 76

Leading therapy areas in Japan 78

Cardiovascular drugs hold the largest value share of the Japanese market 80

Immunology and inflammation drugs have exhibited the fastest growth following approval of biologic drugs 81

The musculoskeletal market is contracting due to intensifying generic competition 81

Oncology drugs will drive market growth out to 2015 81

Leading therapy areas out to 2015 (for the top 50 pharma companies) 82

Leading prescription pharmaceutical brands in Japan 83

Blopress is the highest selling brand in Japan but its position may be in jeopardy from 2012 onwards 85

Diovan has been growing strongly thanks to numerous indication approvals 86

Lipitor maintains growth despite the availability of cheaper generic statins 86

Leading pharmaceutical companies in the Japanese prescription pharmaceutical market 87

Roche and Eisai have experienced particularly strong growth in Japan 88

Leading companies out to 2015 91

The leading domestic companies are exhibiting modest growth rates 92

Takeda 93

Daiichi Sankyo 94

Mitsubishi Tanabe 94

5. Japan - Drug expiry analysis 95

Key findings 95

Japan generics market 95

Japan brand erosion post patent expiry 95

Japan biosimilars market 95

Japan generics market dynamics 97

Japan generics volume uptake 98

Japan generics value uptake 99

Japan generics market size 100

Drivers and resistors in the Japanese generics market 101

Japan's generics market has shown steady growth 103

Healthcare providers reluctant to use generics 103

Physicians require greater incentive to prescribe generics 104

New prescription forms have yet to realize their potential 104

Financial incentives for physicians are lacking 104

Pharmacists present obstacles to generic uptake 105

Generic dispensing rate must be improved 105

Pharmacist compensation offset by administrative costs 105

Pharmacist premium set for revision 106

Hospitals represent a potentially important driver of generics uptake 106

Generics prescribing in hospitals subject to institution-wide policy 106

Diagnosis Procedure Combination hospitals will drive uptake 106

Quality holds the upper hand in Japan 107

Improving information provision 107

Imposing quality control for generics 107

Twice-yearly pricing opportunity for manufacturers allows generics to enter the market more rapidly 108

Generics supply and distribution is gradually improving 109

Manufacturers continue to build wholesaler ties 109

The industry moves to ensure stable generics supply 109

Initiatives to raise awareness/trust for patients and healthcare providers 109

Financial incentive for patients is lacking 110

Biennial price cuts a resistor to generics uptake 111

A cost-sensitive population beginning to emerge 111

Key generics players in the Japanese market 112

Opportunities for the generics industry 112

Company strategy in Japan 113

Domestic industry set for massive consolidation 114

Domestic branded players entering the Japanese generics market 114

Hospital focused Nichi-Iko enters joint venture with Sanofi-Aventis 115

Sawai seeks capital tie up 115

Non-traditional companies entering the drugs sector 115

Multinationals compete to enter the Japanese generics market 116

Teva beefs up Japanese presence with domestic support 116

Mylan to expand in Japan 116

Actavis to expand in Japan 117

Pfizer to become a major generics player in Japan 117

Sanofi-Aventis teams up with Nichi-iko 117

Small molecule brand erosion in Japan 118

Overview of drugs analyzed 118

Mean level of brand erosion in Japan 119

Brand erosion in the Japanese retail and hospital setting 120

Brand erosion by therapy area in Japan 121

Brand erosion by drug formulation in Japan 123

Japan biosimilars market dynamics 124

Key players in the Japan biosimilars market 124

Sandoz maintains pioneer status with launch of Omnitrope in Japan 125

First epoetin biosimilar approved in Japan 125

GlaxoSmithKline gains rights to biosimilar epoetin 125

Companies set to enter the biosimilars market 126

Opportunities for the biosimilar industry 126

Branded monoclonal antibody therapies could soon face biosimilar incursion 128

Biosimilars in development internationally 129

6. Japan - Pharmaceutical Industry Infrastructure analysis 131

Key findings 131

Pharmaceutical industry infrastructure overview 131

Japanese pharmaceutical industry infrastructure overview 132

R&D and manufacturing strategies in Japan 132

Key company infrastructure in Japan 134

Pfizer 135

Daiichi Sankyo 144

Daiichi Sankyo sells a manufacturing plant and non-core chemicals business 148

Mitsubishi Tanabe 149

Mitsubishi Tanabe expands in the generics market 152

Roche 153

Roche increases its stake in Chugai to secure access to new innovative therapies 157

Novartis 158

Astellas Pharma 162

Merck & Co. 165

Eisai 168

Otsuka 172

Otsuka enhances peptide production capabilities through the acquisition Ito Life Sciences 176

7. Bibliography 177

Japan - Executive summary 177

Publications and online articles 177

Datamonitor reports and products 177

Japan - Socio-demographic and economic analysis 178

Publications and online articles 178

Japan - Healthcare systems and regulations 180

Publications and online articles 180

Datamonitor reports and products 183

Japan - Prescription pharmaceutical sales 184

Publications and online articles 184

Datamonitor reports and products 184

Japan - Drug expiry analysis 184

Publications and online articles 184

Datamonitor reports and products 190

Japan - Pharmaceutical industry infrastructure analysis 190

Publications and online articles 190

Datamonitor reports and products 191

APPENDIX 192

Exchange rates used in this report 192

Japan brand erosion - additional data and analysis 193

Brand erosion - methodology 195

Datamonitor prescription pharmaceutical definition and therapy area classification 198

About Datamonitor 199

About Datamonitor Healthcare 199

Datamonitor consulting 199

Disclaimer 200

Disclaimer 201

List of Tables

Table 1: Japan - changes in the key value drivers of the Japanese pharmaceutical market, 2005-09 5

Table 2: Japan - demographic indicators, 2005 and 2010 7

Table 3: Japan - key economic indicators, 2005-2012 8

Table 4 10

Table 4: Japan - healthcare expenditure indicators, 2006-09 10

Table 5: Japan - a range of pricing and reimbursement tools are used, 2010 12

Table 6: Japan - sales and volume of the pharmaceutical market ($ and IMS Standard Units), 2009 14

Table 7: Japan - key metrics for the generics and biosimilars market, 2010 16

Table 8: Japan - R&D and manufacturing infrastructure data, 2010 18

Table 9: Japan - demographic indicators, 2005 and 2010 22

Table 10: Japan - top 10 causes of mortality, 2004 28

Table 11: Japan - disability-adjusted life years (DALY) rates compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 2004 30

Table 12: Japan - key economic indicators, 2005-2012 32

Table 13 40

Table 13: Japan - healthcare expenditure indicators, 2006-09 40

Table 14: Japan - hospital bed and healthcare worker density 2000-07 49

Table 15: Japan - a range of pricing and reimbursement tools are used, 2010 60

Table 16: Japan - price premiums are given to drugs that can demonstrate a level of innovation, 2010 66

Table 17: Japan - sales and volume of the pharmaceutical market ($ and IMS Standard Units), 2009 77

Table 18: Japan - pharmaceutical sales by therapy area ($m and %), 2005-09 79

Table 19: Japan - pharmaceutical volume by therapy area (SUm and %), 2005-09 80

Table 20: Japan - sales growth for top 20 pharmaceutical brands (%), 2009 84

Table 21: Japan - volume growth for top 20 pharmaceutical brands, 2009 85

Table 22: Japan - sales growth for the top 10 pharmaceutical companies ($ and %), 2009 89

Table 23: Japan - volume growth for the top 10 pharmaceutical companies (SU and %), 2009 90

Table 24: Japan - sales growth for the leading Japan-based pharmaceutical companies ($ and %), 2009 92

Table 25: Japan - volume growth for the leading Japan-based pharmaceutical companies (SU and %), 2009 93

Table 26: Japan - key metrics for the generics and biosimilars market, 2010 96

Table 27: Japan - comparison of generic penetration versus other major pharmaceutical markets ($ billion and %), 2007-08 97

Table 28: Japan - reforms that have impacted generics uptake, 2002-10 102

Table 29: Japan - generics chosen to be quality checked by Korosho (Japan's ministry of health, labor and welfare) in Japan, 2010 108

Table 30: Japan - brands exposed to generic competition, 2010-12 112

Table 31: Japan - leading biosimilar companies, 2010 124

Table 32: Japan - sales (based on 2009 sales data) of biologics both expired and expected to come off-patent, 2010-15 127

Table 33: Japan - sales growth for the top 10 pharmaceutical companies ($m and %), 2009 134

Table 34: Japan - Pfizer's R&D and manufacturing infrastructure (post-merger with Wyeth), 2010 135

Table 35: Japan - Pfizer's R&D and manufacturing infrastructure data (post-merger with Wyeth) compared with other top 10 companies in Japan, 2010 136

Table 36: Japan - Takeda's R&D and manufacturing infrastructure, 2010 139

Table 37: Japan - Takeda's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 140

Table 38: Japan - Takeda's domestic M&A activity, Q1 2008-Q1 2010 143

Table 39: Japan - Daiichi Sankyo's R&D and manufacturing infrastructure, 2010 144

Table 40: Japan - Daiichi Sankyo's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 145

Table 41: Japan - Daiichi Sankyo's domestic M&A activity, Q1 2008-Q1 2010 148

Table 42: Japan - Mitsubishi Tanabe's R&D and manufacturing infrastructure, 2010 149

Table 43: Japan - Mitsubishi Tanabe's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 150

Table 44: Japan - Mitsubishi Tanabe's domestic M&A activity, Q1 2008-Q1 2010 152

Table 45: Japan - Roche's R&D and manufacturing infrastructure, 2010 153

Table 46: Japan - Roche's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 154

Table 47: Japan - Roche's domestic M&A activity, Q1 2008-Q1 2010 157

Table 48: Japan - Novartis's R&D and manufacturing infrastructure, 2010 158

Table 49: Japan - Novartis's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 159

Table 50: Japan - Astellas's R&D and manufacturing infrastructure, 2010 162

Table 51: Japan - Astellas's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 163

Table 52: Japan - Merck & Co's R&D and manufacturing infrastructure (post acquisition of Schering-Plough), 2010 165

Table 53: Japan - Merck & Co.'s R&D and manufacturing infrastructure data (post acquisition of Schering-Plough) compared with other top 10 companies in Japan, 2010 166

Table 54: Japan - Eisai's R&D and manufacturing infrastructure, 2010 168

Table 55: Japan - Eisai's R&D and manufacturing infrastructure data compared with other top 10 companies in Japan, 2010 169

Table 56: Japan - Otsuka's R&D and manufacturing infrastructure, 2010 172

Table 57: Japan - Otsuka's R&D and manufacturing infrastructure data compared with other originator companies in the top 10 in Japan, 2010 173

Table 58: Japan - Otsuka's domestic M&A activity, Q1 2008-Q1 2010 176

Table 59: Currency exchange rates, 2010 192

Table 60: ATC (anatomical therapeutic chemical) classification codes assigned to a given therapy area within the prescription pharmaceutical market 198

List of Figures

Figure 1: Japan - key value drivers of Japan's pharmaceutical market, 2009 4

Figure 2: Japan - drivers and resistors facing branded pharmaceutical companies 6

Figure 3: Japan - Population and population growth rate, 1950-2050 23

Figure 4: Japan - population growth compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 1950-2050 24

Figure 5: Japan - birth rates per 1,000 individuals compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 1950-2050 25

Figure 6: Japan - proportion of population over 65 years compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 1950-2050 26

Figure 7: Japan - life expectancy compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 1950-2050 27

Figure 8: Japan - GDP per capita growth rate compared to Australia, the BRIC nations, North America and five major EU markets (5EU), 2005-09 33

Figure 9: Debt trap rankings for Japan, the five major EU markets, North America, and Australia, 2010 34

Figure 10: Unemployment rates in Japan, the five major EU markets, North America, the BRIC nations and Australia, 1990-2008 36

Figure 11: Japan - healthcare expenditure indicators, 2006 39

Figure 12: Japan - healthcare costs are set to rise dramatically to 2035 41

Figure 13: Japan - structure of the public health insurance system, 2010 42

Figure 14: Japan - Flow of funds within the healthcare system, 2010 43

Figure 15: Japan - a range of bodies and groups impact the country's healthcare provision 44

Figure 16: Japan - Cost-containment is largely absent or ineffectual 50

Figure 17: Japan - Structure of the drug regulatory system 53

Figure 18: Japan - drug approval process, 2010 54

Figure 19: Japan - drug price (Yakka) setting process for new products, 2010 62

Figure 20: Japan - pricing of new drugs differs depending on whether similar alternatives exist, 2010 64

Figure 21: Japan - biennial price revision 68

Figure 22: Japan - medical fee revision, April 2010 69

Figure 23: Japan - components of the biennial drug price revision, April 2010 70

Figure 24: Japan - drug pricing reforms bring mainly bad news for Pharma 71

Figure 25: Japan - relative sales and volume of the Japanese pharmaceutical market (indexed against volume or value in 2005), 2005-09 76

Figure 26: Japan - pharmaceutical sales by therapy area (%), 2005-09 78

Figure 27: Japan - sales forecast for the top 50 global pharma companies by therapy area ($ billion), 2010-15 82

Figure 28: Japan - sales growth for the leading pharmaceutical brands ($m and %), 2009 83

Figure 29: Japan - sales growth for leading pharmaceutical companies (%), 2005-09 87

Figure 30: Japan - sales forecast for the top 10 pharma companies in Japan ($ billion), 2010-15 91

Figure 31: Japan - comparison of generic volume uptake versus other major pharmaceutical markets (%), 2007-08 98

Figure 32: Japan - comparison of generic value uptake versus other major pharmaceutical markets (%), 2007-08 99

Figure 33: Japan - comparison of generics market size in Italy versus other pharmaceutical markets, 2007-08 100

Figure 34: Japan - key factors influencing the generic industry, 2010 101

Figure 35: Japan - growth of generics market, 2005-2010 103

Figure 36: Japan - brand sales at risk of generic erosion ($m), 2010-12 113

Figure 37: Japan - mean erosion (by value and volume) of branded small molecules during the first 2 years of generic competition 119

Figure 38: Japan - mean erosion (by value and volume) of branded small molecules by prescribing setting during the first 2 years of generic competition 120

Figure 39: Japan - mean erosion (by value and volume) of branded small molecules by therapy area in the Japanese market during the first 2 years of generic competition 121

Figure 40: Japan - sales of tablet forms of mesalazine (by value and volume) in the first six quarters of generic competition 122

Figure 41: Japan - mean erosion (by value and volume) of branded small molecules by formulation during the first 2 years of generic competition 123

Figure 42: Japan - sales (based on 2009 sales data) of biologics expected to come off-patent, 2010-15 126

Figure 43: Drivers and resistors to biosimilar monoclonal antibody entry, 2010 129

Figure 44: Japan - key biosimilars in development internationally by product class, 2010 130

Figure 45: Pharma's strategic responses to slowing sales and operating profit growth 133

Figure 46: Japan - Pfizer's presence (post-merger with Wyeth) compared with other top 10 companies in Japan, 2010 137

Figure 47: Japan - Pfizer's pharmaceutical operations (post-merger with Wyeth), 2010 138

Figure 48: Japan - Takeda's presence compared with other top 10 companies in Japan, 2010 141

Figure 49: Japan - Takeda's pharmaceutical operations, 2010 142

Figure 50: Japan - Daiichi Sankyo's presence compared with other top 10 companies in Japan, 2010 146

Figure 51: Japan - Daiichi Sankyo's pharmaceutical operations, 2010 147

Figure 52: Japan - Mitsubishi Tanabe's pharmaceutical operations, 2010 151

Figure 53: Japan - Roche's presence compared with other top 10 companies in Japan, 2010 155

Figure 54: Japan - Roche's pharmaceutical operations, 2010 156

Figure 55: Japan - Novartis's presence compared with other top 10 companies in Japan, 2010 160

Figure 56: Japan - Novartis's pharmaceutical operations, 2010 161

Figure 57: Japan - Astellas's pharmaceutical operations, 2010 164

Figure 58: Japan - Merck & Co.'s pharmaceutical operations (post acquisition of Schering-Plough), 2010 167

Figure 59: Japan - Eisai's presence compared with other top 10 companies in Japan, 2010 170

Figure 60: Japan - Eisai's pharmaceutical operations, 2010 171

Figure 61: Japan - Otsuka's presence compared with other top 10 companies in Japan, 2010 174

Figure 62: Japan - Otsuka's pharmaceutical operations, 2010 175

Figure 63: Japan: sales erosion of branded small molecules during the first 2 years of generic competition 193

Figure 64: Japan: volume erosion of branded small molecules during the first 2 years of generic competition 194

Figure 65: Drugs experiencing generic erosion between Q1 2006 and Q2 2007 195

Figure 66: Erosion curves for each drug experiencing generic entry 196

Figure 67: Mean erosion curve for drugs A, B, and C experiencing generic entry 197

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