Profitability Assessment of Branded Generic Inhalers
Profitability Assessment of Branded Generic Inhalers
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We set out to examine the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products.
Publisher: Datamonitor Healthcare
- Description
- Contents
- Samples
We set out to examine the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products. Our analysis shows that, in some cases, sufficiently attractive financial gains cannot be expected beyond the first few market entrants, as indicated by the appearance of negative net present values for later entrants. This emphasizes the importance of developers paying close attention to, and making frank assessments of, their ability to reach the market ahead of their competitors.
Table of Contents
5 EXECUTIVE SUMMARY
7 INTRODUCTION
8 Bibliography
10 REGULATORY LANDSCAPE REVIEW
10 Regulatory pathway in Europe
17 Regulatory pathway in the US
24 Regulatory pathway summary
25 Bibliography
27 FORECASTING AND ECONOMIC ASSESSMENT
27 Forecasting approach
31 US: Advair forecast
32 EU: Symbicort and Advair forecast
35 Profit and loss analysis
40 Economic appraisal
43 Bibliography
45 CONCLUSION
46 APPENDIX 1
47 APPENDIX 2
48 BIOGRAPHIES
LIST OF FIGURES
27 Figure 1: Patient flow diagram
28 Figure 2: Potential uptake curves diagram
31 Figure 3: Forecast assumptions for Advair Gx/BGx
33 Figure 4: Forecast assumptions for Symbicort BGx
34 Figure 5: Forecast assumptions for Advair BGx
LIST OF TABLES
13 Table 1: Clinical trials conducted to support the approvals of AirFluSal Forspiro, DuoResp
Spiromax, and Bufomix Easyhaler
18 Table 2: FDA guidance for bioequivalent AB-rated Advair generics
21 Table 3: Comparison of development pathway for Mylan MGR001 vs Teva FS Spiromax
22 Table 4: Comparison of development pathway for Teva ProAir Spiromax vs SkyePharma
Flutiform
30 Table 5: Zipf market share distribution
36 Table 6: Clinical trial costs per patient, by phase
37 Table 7: Costs for clinical trials conducted by Teva for DuoResp Spiromax
38 Table 8: Device development: a review of respiratory device transactions
41 Table 9: Advair Gx/BGx US: summary P&L
41 Table 10: Advair BGx EU: summary P&L
42 Table 11: Symbicort BGx EU: summary P&L
Figure 2: Potential uptake curves diagram
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