Generics Series: Authorized Generics Analysis

Table of Contents

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Methodology
• Datamonitor insight into the disease market
• Related reports

AUTHORIZED GENERICS OVERVIEW

• Authorized generics as a tool for branded pharma to maximize market share
• The generics industry is split on the issue of authorized generics
• The impact of authorized generics on the consumer

FREQUENCY AND TYPE OF AUTHORIZED GENERICS AGREEMENTS

• The frequency of authorized generic agreements through 2008
  • Authorized generic agreements on the rise
  • The number of authorized generic agreements apparently peaked in 2006
• Decisions regarding brand-generic authorized generic partnerships
  • Small and mid-sized generic companies benefit most from authorized generic deals
  • Own generics dominate the authorized generics landscape in the US

CORRELATION BETWEEN BRAND VALUE AND GENERIC EROSION

• Brand market size and number of generic entrants
• Success of authorized generic launch by brand value
• Average generic erosion of brands by value
  • Brands with pre-generic quarterly revenues of less than $100m
  • Brands with pre-generic quarterly revenues between $100m and $200m
  • Brands with pre-generic quarterly revenues between $200m and $400m
  • Brands with pre-generic quarterly revenues between $400m and $600m
  • Brands with pre-generic quarterly revenues in excess of $600m

CORRELATION BETWEEN THERAPEUTIC CLASS AND GENERIC EROSION

• Brand therapeutic category and number of authorized generic launches
• Success of authorized generic launch by therapeutic class
  • Authorized generics within the immune and inflammatory disease, and central nervous system disorder classes lost little market share over 2 years
  • Authorized generics within the genitourinary, cardiovascular, and endocrine and metabolic disease classes lost most market share over 2 years
• Average generic erosion of brands by therapy class
  • Cardiovascular disease brands
  • Infectious disease brands
  • Central nervous system disease brands
  • Endocrine and metabolic disease brands
  • Oncology brands
  • Immune and inflammatory disease brands
  • Genitourinary disease brands
  • Respiratory disease brands

CORRELATION BETWEEN DOSAGE FORM AND GENERIC EROSION

• Dosage form and number of authorized generic launches
• Success of authorized generic launch by brand dosage form
  • Authorized generics within the transdermal and oral solution classes lost little market share over 2 years
  • Authorized generics within the standard oral solids and injectable classes lost the greatest market share over 2 years
• Average generic erosion by brand dosage form
  • Standard oral solid dose brands
  • Specialty oral solid dose brands
  • Oral solution brands
  • Injectable brands
  • Transdermal brands

THE AUTHORIZED GENERICS OUTLOOK

• Closing the Hatch-Waxman loophole
• Reverse-payment scrutiny should not impact on authorized generics use
• Own authorized generics use set to grow
• Emergence of novel late-stage lifecycle management strategies
  • Risk management plans hold up generic approvals
  • Generics in transit fall prey to customs regulations

BIBLIOGRAPHY

• Publications and online articles
• Company press releases
• Datamonitor reports

APPENDIX

• Authorized generics agreements
• Exchange rates

TABLES

• Table: Authorized generic agreements in the US, 2004-08
• Table: Currency exchange rates, 2008

FIGURES

• Figure: Final settlement agreements which included AG provisions in the US, fiscal years 2004 08
• Figure: Key drivers and resistors for authorized generic agreements
• Figure: Authorized generic agreements in the US, 2004  08
• Figure: Authorized generic agreements in the US between 2004 and 2008
• Figure: Correlation between number of generic entrants and branded market size in the 2 years following generic market entry in the US, 2004 08
• Figure: Authorized generic volume market share dynamics by brand value in the US, 2004 08
• Figure: 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
• Figure: 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
• Figure: 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
• Figure: 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
• Figure: 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
• Figure: Authorized generic agreements by therapeutic class , 2004 08
• Figure: Authorized generic volume market share dynamics across therapeutic classes in the US, 2004 08
• Figure: Generic erosion of cardiovascular brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of infectious disease brands in the US in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of central nervous system brands in the US in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of endocrine and metabolic disease brands in the US in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of oncology brands in the US in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of immune and inflammatory disease brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of genitourinary disease brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of respiratory disease brands in the US in the 2 years following generic market entry in the US, 2004 08
• Figure: Authorized generic agreements by dosage form in the US, 2004 08
• Figure: Authorized generic volume market share dynamics by dosage form in the US, 2004 08
• Figure: Generic erosion of standard oral solid dose brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of specialty oral solid dose brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion for branded oral solution products in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion of injectable brands in the 2 years following generic market entry in the US, 2004 08
• Figure: Generic erosion for transdermal brands in the 2 years following generic market entry in the US, 2004 08
• Figure: The pathway to generic approval in the US
• Figure: Brand lifecycle management strategies