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Published by: Datamonitor
Published: Jul. 24, 2003 - 52 Pages
Table of Contents
EXECUTIVE SUMMARY
Introduction
Scope and coverage of the Brief
Key findings about patent expiries and generic competition
In markets where the R&D pipeline offers little innovative product development, generic incursion is both more rapid and sustained than in those markets which are constantly evolving. However, in these markets, competition between generics manufacturers is more intense, creating a greater need for generic differentiation
Generic defense strategies are currently limited in scope, having only minimal benefit in preserving sales. The timing of follow-up products and significant investment in physician education are essential to the success of such strategies.
The widespread use of generics has led to resistance increasing across the infectious disease therapy area. Although generics offer a cost efficient treatment option in the short term, their contribition to increased resistance could lead to greater costs of therapy, associated with recurring and more severe infections
ANTIBACTERIAL MARKET
Disease and market definition
Uptake of generic antibacterials
Drivers of uptake
Clinical drivers
Short treatment lengths
Cost constraints
Pharmacist substitution
Commercial drivers
Resistors of uptake
Clinical factors - resistance fears
Commercial factors
Manufacturing constraints
Weaker sales performance
Key patent expiries
Generic defence strategies
Follow-up products
Case study: Augmentin and Biaxin
Augmentin
Biaxin
Comparison of strategies
Indication expansion
Case study: Zithromax
HIV
Disease and market definition
Future uptake of generic HIV drugs
Drivers of uptake
Commercial
Atrractive market conditions
Less developed world markets
Resistors of uptake
Clinical
High innovation in R&D
Commercial
Poor distribution networks in emerging markets
Key patent expiries
Manufacture of generic drugs
ANTIFUNGALS
Disease and market definition
Uptake of generic antifungals
Drivers of uptake
Clinical
Short treatment lengths
Commercial
Increased patient potential and OTC status drives manufacturer interest
Resistors of uptake
Clinical
Drug-resistance
Key patent expiries
Diflucan
Lamisil
Sporanox
Generic defence strategies
Prescription to OTC switching
Case study: Lamisil
Line extensions
HERPES
Disease and market definition
Herpes simplex virus
Varicella zoster virus
Cytomegalovirus
Epstein Barr virus
Uptake of generic herpes treatments
Drivers of uptake
Clinical - lack of innovative new products
Commercial
Resistors of uptake
Clinical
Reluctance to treat
Failure to present
Key patent expiries
Generic defense strategies
Case study: GSK’s Zovirax
Strong brand awareness in the EU
Valtrex to build on existing portfolio strength and improved dosing
SUMMARY
Ease of generic penetration
Market maturity
Disease profile
Likelihood of generic success
Brand awareness
Bibliography
Articles
Websites
Disclaimer
List of Tables
Table 1: Key patent expiries in antibacterials to 2007
Table 2: Sales decline following key antibacterial patent expiries
Table 3: Cipro global patent expiries and impact on sales
Table 4: Leading HIV drugs in each class, 2002
Figure 6: Global sales of Retrovir, 1987-2002
Table 5: Key patent expiries of current marketed HIV products
Table 6: Selected key patent expiries in antifungals
Table 7: Key patent expiries in the herpes market
List of Figures
Figure 1: Total US Augmentin prescriptions, 2003
Figure 2: Biaxin sales, 1995-2011
Figure 3: Augmentin sales, 1995-2011
Figure 4: Zithromax sales, 1995-2011
Figure 5: Zinnat sales, 1995-2011
Figure 7: Canesten products and indications
Figure 8: Attractiveness of selected infectious disease markets to generic competition
AbstractIntroduction
Over the next 5 years, key products across the major infectious disease sectors are set to face patent expiry. With generics manufacturers lining up to produce cheaper equivalent products, companies will face significant challenges to maintain franchise sales. This brief will analyze the impact of such patent expiries in the antibacterial, HIV, herpes and fungal infection fields.
Scope
Detailed analysis of forthcoming patent expiries in the antibacterial, HIV, antifungal and herpes markets
Contrasting generic success in the HIV markets of the developed and developing world
A number of case studies and past examples are used to illustrate successful defense strategies across the infectious disease therapy area
A number of market leading drugs, that have or are about to lose patent, are analyzed, including Augmentin, Diflucan and Zovirax
Report Highlights
The antibacterial and antifungal markets are the more attractive for generics manufacturers, with relatively easy market penetration and a high likelihood of success.
The HIV market has yet to experience patent expiry. However, the import of generics into the developing world is widespread, creating a ‘two-tiered’ generics market.
Generic defense strategies, while limited in scope, have been proven to restrict the impact of generic competition and can be employed in all markets to protect sales.
Reasons to Purchase
Quantify the different impacts of generic incursion across the key infectious disease markets
Identify key defense strategies used across infectious disease sectors to maintain sales following patent expiry
Understand why some infectious disease markets are vulnerable to generic competition while others are not
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