Business Insights: Optimizing Lifecycle Management

The need to derive the maximum commercial mileage from all components of a drug company’s portfolio is clearly evident in an era of falling returns on investment and higher capital costs.

This report investigates three goals in optimizing product potential—expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations. The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics.

Optimizing Lifecycle Management: Maximizing commercial lifespan through label expansion and combination products explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.

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Key findings from this report

Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project.

The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments.

Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.

Scope of this report

• In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.
• Analysis of historic drug approval data provides the reader with contextual reference points.
• Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.
• Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.
• Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.
• Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.

You can use this report to

• Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management
• Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.
• Understand the stance of key stakeholders and implications of off-label drug usage.
• Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization
• Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure

Click here to view a sample of this report.