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Published by: Business Insights
Published: Aug. 4, 2004 - 98 Pages
Table of Contents
Executive summary
Introduction
- Market overview
- Successful US strategies
- Successful European strategies
- US legislation and its impact
- European legislation and its impact
- US barriers to generics growth
- European barriers to generics growth
- Future prospects and conclusions
Chapter 1 Market overview
- Summary
- Introduction
- US vs Europe - differences and contradictions
- Global opportunities - forthcoming patent expiries
- Underdeveloped markets
- Expand abroad or stay at home?
- Multinational R&D companies’ involvement in generics
- Chapter 2 Successful US strategies
- Summary
- Overview of US generic market
- Leading US generic companies
- The road to success
- Distribution of commodity generics
- Manufacture and distribution of commodity generics
- Acquisition
- Patent challenges - Paragraph IV filings and first to file
- Specialty generics - reducing the competition levels
- Products with technologically challenging formulations
- Controlled release generics
- Products where significant regulatory support is required
- Products with limited availability of the API
- Proprietary drugs — branded and generic products together
- Biogenerics
Chapter 3 Successful European strategies
- Summary
- Overview of European generic markets
- Pricing
- Intellectual property
- Generic prescribing levels
- Purchasing decision based on price
- Pricing based on supply and demand
- Leading European companies
- The road to success
- Distribution of commodity generics
- Manufacture and distribution of commodity generics
- Patent challenges
- Be first to launch
- Acquisition
- Specialty generics - reducing the competition levels
- Proprietary drugs - branded products alongside generics
- Biogenerics
Chapter 4 US legislation and its impact
- Summary
- Overview of US generic legislation
- Hatch-Waxman amendments
- Benefits to the R&D side
- Benefits to the generic side
- Disadvantages of the legislation
- McCain-Schumer legislation
- Gregg-Schumer Act
- The impact of new legislation
- Single 30 month stay
- Orange Book listings
- 180-day exclusivity
- Authorized generics
- Bioequivalence
Chapter 5 European legislation and its
- impact
- Summary
- Overview of European generic legislation
- Directive 2001/83
- Directive 2004/27/EC
- Benefits to the R&D side
- Benefits to the generic side
- The impact of new legislation
- Definition of a generic
- Bolar clause
- “Is Marketed”
- European Reference Product
- Harmonization of SmPC’s
- Disadvantages of the legislation - winners and losers
- Other IP issues
Chapter 6 US barriers to generics growth
- Summary
- Introduction
- Threats to the industry
- Market saturation
- Increasing wholesaler consolidation
- Overseas competitors - India
- Overseas competitors - Europe
- Gaps in patent expiries
- Reference prices
- Parallel imports
- Individual company strategies
- Movement away from normal release oral commodity generics
- Adjustment of product portfolio to include higher margin products
- Investment in original R&D
- Acquisitions
- Expansion into overseas markets
- Alliances with overseas manufacturers in India or Latin America
- Biogenerics
- The role of trade associations
Chapter 7 European barriers to generics
- growth
- Summary
- Overview
- Threats to the industry
- Market saturation
- Increasing wholesaler consolidation
- Overseas competitors - India
- Overseas competitors - Europe
- Reference prices
- Parallel imports
- Individual company strategies
- Portfolio adjustment
- Expand abroad
- Attack patents - risks and opportunities
- Form an alliance with multinational
- Conduct own R&D
- Biogenerics
- Add parallel imports to the range
- Enter OTC market
- The role of trade associations
- Lobby for legislative change
- Lobby against legislative change
Chapter 8 Future prospects and conclusions
- Summary
- Overview
- Trends in manufacturing
- Movement of manufacturing facilities
- Threats to generics companies
- Trends in marketing
- Movement upstream
- Expansion overseas
- Target areas for expansion
- The future of generics in the US
- US profit margins
- Future legislative changes
- The future of generics in Europe
- Pan-European generics
- Legislation
- IP Problems
- The generics competitive landscape
- Generic superheroes
- Consolidation of generic companies
- Branded pharmaceutical company consolidation
- Growth prospects for generics
- Outlook by therapeutic area
List of Figures
- Figure 1.1: Examples of differences between US and Europe (as at start of 2004)
- Figure 1.2: Generic penetration in Europe
- Figure 2.3: Significant factors necessary for the development of a healthy generic market
- Figure 2.4: Branded sales and sales growth of the leading generics companies, 2000-01
- Figure 3.5: Factors necessary for the development of a healthy generic market
- Figure 3.6: European sales of leading generics players, 2001
- Figure 6.7: The value of major US patent expiries to 2008
- Figure 6.8: Generics R&D strategies - trade off between risk and competition level
- Figure 6.9: Drivers and resistors to geographic expansion
- Figure 7.10: European prices compared against reference price systems
- Figure 7.11: Pharmaceutical prices and generic penetration in Europe
- Figure 8.12: Generic penetration rates in Europe, 2003
- Figure 8.13: Opportunities and saturation in generics markets
- Figure 8.14: Threats to generics companies
- Figure 8.15: The evolution of successful generics companies
- Figure 8.16: Plans for overseas expansion
- Figure 8.17: Target areas for expansion
- Figure 8.18: Use of regional offices, subsidiaries, acquisition and local agents
- Figure 8.19: The impact of recent changes in pharmaceutical law
- Figure 8.20: Annual growth predictions for generic drugs, 2004, responses by type of company
- Figure 8.21: Annual growth predictions for generic drugs, 2004, responses by location of
- respondents
- Figure 8.22: Most attractive therapy areas for generic drugs growth
List of Tables
- Table 1.1: Size of key generics markets, 2001-02
- Table 1.2: Best selling pharmaceuticals (2003) and their patent expiry dates
- Table 2.3: Major generic companies in the US market 2002
- Table 2.4: Generics players and their subsidiaries (selected list)
- Table 3.5: Comparison of different national pharmaceutical price levels, 2000
- Table 3.6: Generics players and their subsidiaries (selected list)
- Table 4.7: Comparison of major legislative provisions in the US
- Table 5.8: EU members and their date of accession
- Table 5.9: Generic substitution by country in Europe (as at February 2004)
- Table 5.10: EU data exclusivity times as at early 2003
- Table 6.11: Key US patent expiries, 2001-2006
- Table 7.12: European price comparisons, 1996-2003
- Table 7.13: European reference pricing systems in each country, by type
- Table 7.14: Biologics patent expiries, 2001-2006
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