Home > Market Research > Prescriptipn Medicines > Generics Series: Authorized Generics Analysis

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Report
Published: July 2009
Pages: 76
Tables: For full details, please email keithw@cmsinfo.com
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Research from: Datamonitor
Sector: Prescriptipn Medicines

Introduction

While the benefits of authorized generics to the branded industry are clearly apparent, the attitude of the generics industry is determined by individual company strategy. For those generics players that aggressively challenge patents, authorized generics are a threat to revenues, while for other smaller companies, authorized generics represent an opportunity to get to market quickly and easily.

Scope

*An overview of the authorized generics landscape, including drivers and resistors for both branded and generics players.

*An insight into which branded and generics companies entered into authorized generics agreements in the US between 2004 and 2008.

*Analysis of the extent of authorized generic market share capture during 2 years following launch, by brand value, therapeutic class, and dosage form.

*An overview into what the future holds for authorized generics, in the US and Europe.

Highlights

Given the benefits associated with own authorized generics, it is unsurprising that these dominated the data-set under investigation, with the Pfizer-Greenstone authorized generic combination by far the most frequent.

The authorized generic launched at a greater discount to the branded drug than the conventional generic, in 65% of agreements under analysis, reflecting the higher margins available to the authorized generics company which potentially neither developed, manufactured, or obtained approval to market the drug.

The greatest number of generic entrants was associated with the highest value branded products (with pre-generic quarterly sales in excess of $600m) in the data-set under analysis, with this group showing an average of 14 and 19 competitors at 1 and 2 years post generics launch.

Reasons to Purchase

*Understand what authorized generics are, and the strategic motivations which drive companies to use them.

*Understand the effect of brand value, therapeutic class, and dosage form on the relative success of authorized generics to gain generics market share.

*Gain an insight into how the authorized generics landscape will evolve in the future.

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Table of Contents

ABOUT DATAMONITOR HEALTHCARE 2
About the Strategic Pharmaceutical Analysis Team 2
Executive Summary 3
Strategic scoping and focus 3
Methodology 3
Datamonitor insight into the disease market 4
Related reports 6
Table of Contents 7
Chapter 1 Authorized generics overview 8
Authorized generics as a tool for branded pharma to maximize market share 8
The generics industry is split on the issue of authorized generics 10
The impact of authorized generics on the consumer 11
Chapter 2 frequency and type of authorized generics agreements 12
The frequency of authorized generic agreements through 2008 12
Authorized generic agreements on the rise 12
The number of authorized generic agreements apparently peaked in 2006 13
Decisions regarding brand-generic authorized generic partnerships 14
Small and mid-sized generic companies benefit most from authorized generic deals 14
Own generics dominate the authorized generics landscape in the US 15
Chapter 3 Correlation between brand value and generic erosion 17
Brand market size and number of generic entrants 17
Success of authorized generic launch by brand value 19
Average generic erosion of brands by value 20
Brands with pre-generic quarterly revenues of less than $100m 21
Brands with pre-generic quarterly revenues between $100m and $200m 23
Brands with pre-generic quarterly revenues between $200m and $400m 25
Brands with pre-generic quarterly revenues between $400m and $600m 27
Brands with pre-generic quarterly revenues in excess of $600m 29
Chapter 4 Correlation between therapeutic class and generic erosion 31
Brand therapeutic category and number of authorized generic launches 31
Success of authorized generic launch by therapeutic class 33
Authorized generics within the immune and inflammatory disease, and central nervous system disorder classes lost little market share over 2 years 34
Authorized generics within the genitourinary, cardiovascular, and endocrine and metabolic disease classes lost most market share over 2 years 35
Average generic erosion of brands by therapy class 36
Cardiovascular disease brands 37
Infectious disease brands 39
Central nervous system disease brands 41
Endocrine and metabolic disease brands 43
Oncology brands 45
Immune and inflammatory disease brands 47
Genitourinary disease brands 49
Respiratory disease brands 51
Chapter 5 Correlation between dosage form and generic erosion 53
Dosage form and number of authorized generic launches 53
Success of authorized generic launch by brand dosage form 54
Authorized generics within the transdermal and oral solution classes lost little market share over 2 years 55
Authorized generics within the standard oral solids and injectable classes lost the greatest market share over 2 years 55
Average generic erosion by brand dosage form 57
Standard oral solid dose brands 58
Specialty oral solid dose brands 60
Oral solution brands 62
Injectable brands 64
Transdermal brands 66
Chapter 6 The authorized generics outlook 68
Closing the Hatch-Waxman loophole 68
Reverse-payment scrutiny should not impact on authorized generics use 69
Own authorized generics use set to grow 70
Emergence of novel late-stage lifecycle management strategies 71
Risk management plans hold up generic approvals 72
Generics in transit fall prey to customs regulations 72
Chapter 7 Bibliography 73
Publications and online articles 73
Company press releases 74
Datamonitor reports 74
APPENDIX 75
Authorized generics agreements 75
Exchange rates 76
About Datamonitor 77
About Datamonitor Healthcare 77
Datamonitor consulting 77
Disclaimer 79
List of Tables
Table 1: Authorized generic agreements in the US, 2004-08 75
Table 2: Currency exchange rates, 2008 76
List of Figures
Figure 1: Final settlement agreements which included AG provisions in the US, fiscal years 2004-08 8
Figure 2: Key drivers and resistors for authorized generic agreements 10
Figure 3: Authorized generic agreements in the US, 2004-08 13
Figure 4: Authorized generic agreements in the US between 2004 and 2008 15
Figure 5: Correlation between number of generic entrants and branded market size in the 2 years following generic market entry in the US, 2004-08 17
Figure 6: Authorized generic volume market share dynamics by brand value in the US, 2004-08 20
Figure 7: Generic erosion of brands with pre-generic quarterly sales of less than $100m in the 2 years following generic market entry in the US, 2004-08 21
Figure 8: Generic erosion of brands with pre-generic quarterly sales of $100-200m in the 2 years following generic market entry in the US, 2004-08 23
Figure 9: Generic erosion of brands with pre-generic quarterly sales of $200-400m in the 2 years following generic market entry in the US, 2004-08 25
Figure 10: Generic erosion of brands with pre-generic quarterly sales of $400-600m in the 2 years following generic market entry in the US, 2004-08 27
Figure 11: Generic erosion of brands with pre-generic quarterly sales of more than $600m in the 2 years following generic market entry in the US, 2004-08 29
Figure 12: Authorized generic agreements by therapeutic class, 2004-08 31
Figure 13: Authorized generic volume market share dynamics across therapeutic classes in the US, 2004-08 33
Figure 14: Generic erosion of cardiovascular brands in the 2 years following generic market entry in the US, 2004-08 37
Figure 15: Generic erosion of infectious disease brands in the US in the 2 years following generic market entry in the US, 2004-08 39
Figure 16: Generic erosion of central nervous system brands in the US in the 2 years following generic market entry in the US, 2004-08 41
Figure 17: Generic erosion of endocrine and metabolic disease brands in the US in the 2 years following generic market entry in the US, 2004-08 43
Figure 18: Generic erosion of oncology brands in the US in the 2 years following generic market entry in the US, 2004-08 45
Figure 19: Generic erosion of immune and inflammatory disease brands in the 2 years following generic market entry in the US, 2004-08 47
Figure 20: Generic erosion of genitourinary disease brands in the 2 years following generic market entry in the US, 2004-08 49
Figure 21: Generic erosion of respiratory disease brands in the US in the 2 years following generic market entry in the US, 2004-08 51
Figure 22: Authorized generic agreements by dosage form in the US, 2004-08 53
Figure 23: Authorized generic volume market share dynamics by dosage form in the US, 2004-08 54
Figure 24: Generic erosion of standard oral solid dose brands in the 2 years following generic market entry in the US, 2004-08 58
Figure 25: Generic erosion of specialty oral solid dose brands in the 2 years following generic market entry in the US, 2004-08 60
Figure 26: Generic erosion for branded oral solution products in the 2 years following generic market entry in the US, 2004-08 62
Figure 27: Generic erosion of injectable brands in the 2 years following generic market entry in the US, 2004-08 64
Figure 28: Generic erosion for transdermal brands in the 2 years following generic market entry in the US, 2004-08 66
Figure 29: The pathway to generic approval in the US 68
Figure 30: Brand lifecycle management strategies 71

For full details, please email keithw@cmsinfo.com

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