Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
- Number of generic entrants increased over time with more successful
brands experiencing greater levels of competition
- Branded drugs faced revenue erosion of up to 45% after two years of
generic competition
- Generic prices declined rapidly in the free pricing markets of the US
and UK as well as in Germany
- Summary key trends
- CHAPTER 2 INFLUENCE OF PRODUCT AND MARKET SPECIFIC CHARACTERISTICS AT
PATENT EXPIRY
- Overview of the impact of generic drugs on branded drug franchises
- Branded manufacturers faced competition from on average nine generic
entrants, after two years of generic competition
- Branded drugs in the UK and Germany experienced the highest levels
brand value erosion
- Brand erosion - volume versus value
- Brand erosion across the US and 5EU
- While brand prices remained flat following generic entry, generic
prices in the US, Germany and UK gradually declined
- Branded drug price following generic entry
- Generic drug price following generic entry
- CHAPTER 3 FORMULATION SPECIFIC BRAND EROSION
- Introduction
- Number of generic entrants per formulation type
- Standard oral drugs faced competition from nine generic entrants
after two years of generic competition
- The level of generic competition for branded injectable drugs varies
by country
- The level of generic competition for branded topical drugs in the US
remained flat following generic entry
- The majority of generic entrants target standard oral formulations
due to their ease of production, low cost and high usage
- Level of brand value and volume erosion per formulation type
- Branded standard oral drugs experience the greatest level of erosion
in the US
- Branded injectable drugs experienced the greatest level of erosion
in Germany
- Branded oral long-lasting drugs did not experience erosion by
generic standard oral formulations
- Branded topical drug revenues declined by 40% after two years of
generic competition
- Standard oral tablets experienced a greater level of brand erosion
than alternative formulations in the US
- Price of generic drugs per formulation type
- Price of standard oral generics declined by 12% after two years of
generic competition
- Price of generic injectables declined by nearly one-third after two
years of generic competition
- Price of topical generics declined by 21% after two years of generic
competition
- Price of standard oral generics declined more rapidly in the US and
Germany than in the other EU markets
- Price of branded drugs per formulation type following generic entry
- Brand prices of standard oral drugs declined by 30% after generic
entry in Italy, while brand prices in other markets remained flat
- Brand prices of injectable drugs declined by 8% after two years of
generic competition
- Brand prices of topical drugs continued to grow following generic
entry if reformulation strategies are employed
- Oral brand prices increased the least compared to other formulations
following generic entry
- CHAPTER 4 IMPACT OF GENERIC EROSION BY BRAND VALUE
- Introduction
- Brand erosion by revenue size in the US market
- Brands with higher revenues faced a greater number of generic
competitors in the US market
- Branded drugs that are not protected by an effective LCM strategy
experienced a severe decline in revenues following patent expiry
- Relative generic prices were comparable across each brand value
group, and declined to a similar extent over time
- US summary trends
- Brand erosion by revenue size in the French market
- Brands faced greater generic competition over time in the French
market
- Relative generic prices remained flat in France due to the high
mandatory discount on market entry
- French summary trends
- Brand erosion by revenue size in the German market
- Brands with higher revenues faced a greater number of generic
competitors in the German market
- Brands with higher revenues face greater generic erosion in the
German market
- The higher the brand value of the drug, the greater the level and
speed of generic price reductions
- German summary trends
- Brand erosion by revenue size in the Italian market
- Brands in the $10-50m value group faced the greatest number of
generic entrants in Italy
- Branded drugs with technologically advanced delivery systems are
more difficult for generics manufacturers to replicate, providing secure
brand protection
- Relative generic prices remained flat due to the high mandatory
discount on market entry, limiting generic drug profit margins
- Italian summary trends
- Brand erosion by revenue size in the Spanish market
- Brands with higher revenues faced a greater number of generic
competitors in the Spanish market
- Level of brand erosion following generic entry was equivalent for
all brand value groups in the Spanish market
- Relative generic prices remained flat due to the high mandatory
discount on market entry, limiting generic drug profit margins
- Spanish summary trends
- Brand erosion by revenue size in the UK market
- Brands with higher revenues faced a greater number of generic
competitors in the UK market
- Level of brand erosion following generic entry was equivalent for
all brand value groups in the UK market
- Relative generic prices were comparable across each brand value
group, and decline to a similar extent over time
- UK summary trends
- CHAPTER 5 BIBLIOGRAPHY
- Publications and online articles
- Datamonitor reports
- Suggested reading
- Glossary of terms
- APPENDIX
- List of Tables
- Table 1: Overview of the impact of generics on branded drug franchises
across the US and 5EU markets (2003-06) with eight quarters of IMS data
- Table 2: Level of brand franchise volume erosion compared to revenue
erosion (2003-06)
- Table 3: Relative price of branded franchise drug versus generic ($)
- Table 4: Pharmaceutical products analyzed for this report - US
- Table 5: Pharmaceutical products analyzed for this report - France
- Table 6: Pharmaceutical products analyzed for this report - Germany
- Table 7: Pharmaceutical products analyzed for this report - Italy
- Table 8: Pharmaceutical products analyzed for this report - Spain
- Table 9: Pharmaceutical products analyzed for this report - UK
- List of Figures
- Figure 1: There is a strong correlation between declining generic drug
prices and the level of brand erosion after two years of generic incursion
- Figure 2: Prices of generics by formulation during the first two years
following patent expiry compared to branded drug price one quarter prior
to patent expiry in the US and 5EU
- Figure 3: Key summary trends across the US and 5EU markets (2003-06)
- Figure 4: Average number of generic companies entering the market
following a drug patent expiry
- Figure 5: Incentives for generic prescription in Germany
- Figure 6: Number of generic companies entering the US and German
market following a drug patent expiry
- Figure 7: Branded drug franchise volume (SU) and value ($) following
generic entry (%)
- Figure 8: Price of brand and generic drugs in Spain and Italy
following generic entry
- Figure 9: Price of brand and generic drugs in France, Germany, the UK
and US following generic entry
- Figure 10: Disincentives for generic prescription in Italy and Spain
- Figure 11: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry
- Figure 12: Incentives for generic prescription in the UK
- Figure 13: Incentives for generic prescription in France
- Figure 14: Average number of standard oral generic drugs entering the
market following a drug patent expiry
- Figure 15: Average number of injectable generic drugs entering the
market following a drug patent expiry
- Figure 16: Average number of topical generic drugs entering the market
following a drug patent expiry
- Figure 17: Average number of injectable, oral and topical generic
drugs entering the market following a drug patent expiry across the US and
5EU markets
- Figure 18: Revenue shares of leading generics companies by drug
formulation in 2006
- Figure 19: Branded standard oral drug volume (SU) and value ($)
following generic entry (%)
- Figure 20: Incentives for generic prescription in the US
- Figure 21: Total branded injectable drug volume (SU) and value ($)
following generic entry of any formulation (%)
- Figure 22: Branded injectable drug volume (SU) and value ($) facing
direct competition by generic injectables (%)
- Figure 23: Branded topical drug volume (SU) and value ($) following
generic entry (%)
- Figure 24: Branded drug value ($) erosion by formulation following
generic entry (%) in the 5EU and US
- Figure 25: Branded drug formulation and volume (SU) following generic
entry (%) in the 5EU and US
- Figure 26: Average generic drug price of standard oral drugs following
generic entry compared to branded drug price one quarter prior to patent
expiry
- Figure 27: Average generic drug price of injectable drugs following
generic entry compared to branded drug price one quarter prior to patent
expiry
- Figure 28: Volume and relative price of brand and generic version of
mitoxantrone (injectable) in Italy
- Figure 29: Average generic drug price of topical drugs following
generic entry compared to branded drug price one quarter prior to patent
expiry in the US
- Figure 30: Prices of generics by formulation during the first two
years following patent expiry compared to branded drug price one quarter
prior to patent expiry in the US and 5EU
- Figure 31: Average branded standard oral drug price following generic
entry compared to branded drug price one quarter prior to patent expiry
- Figure 32: Average branded injectable drug price following generic
entry compared to branded drug price one quarter prior to patent expiry
- Figure 33: Average branded topical drug price following generic entry
compared to branded drug price one quarter prior to patent expiry
- Figure 34: Average branded standard oral drug price following generic
entry compared to branded drug price one quarter prior to patent expiry
- Figure 35: Average number of generic drugs entering the market
following a drug patent expiry in the US, by brand value
- Figure 36: Branded drug volume (SU) and value ($) following generic
entry (%) in the US, by brand value
- Figure 37: Generic erosion of blockbuster drugs following patent
expiry: Merck' s Zocor (simvastatin) and Forest' s Celexa (citalopram).
- Figure 38: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
the US, by brand value
- Figure 39: US summary trends
- Figure 40: Average number of generic drugs entering the market
following a drug patent expiry in France, by brand value
- Figure 41: Branded drug volume (SU) and value ($) following generic
entry (%) in France, by brand value
- Figure 42: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
France, by brand value
- Figure 43: French summary trends
- Figure 44: Average number of generic drugs entering the market
following drug patent expiry in Germany, by brand value
- Figure 45: Vytorin re-energizes Zocor' s declining German franchise
- Figure 46: Branded drug volume (SU) and value ($) following generic
entry (%) in Germany, by brand value
- Figure 47: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
Germany, by brand value
- Figure 48: German summary trends
- Figure 49: Average number of generic drugs entering the market
following a drug patent expiry in Italy, by brand value
- Figure 50: Branded drug volume (SU) and value ($) following generic
entry (%) in Italy, by brand value
- Figure 51: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
Italy, by brand value
- Figure 52: Italian summary trends
- Figure 53: Average number of generic drugs entering the market
following a drug patent expiry in Spain, by brand value
- Figure 54: Branded drug volume (SU) and value ($) following generic
entry (%) in Spain, by brand value
- Figure 55: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
Spain, by brand value
- Figure 56: Spanish summary trends
- Figure 57: Average number of generic drugs entering the market
following a drug patent expiry in the UK, by brand value
- Figure 58: Branded drug volume (SU) and value ($) following generic
entry (%) in the UK, by brand value
- Figure 59: Average branded and generic drug price following generic
entry compared to branded drug price one quarter prior to patent expiry in
the UK, by brand value
- Figure 60: UK summary trends
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