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Successful Strategies and Innovative Practices for Bringing FDC Products to Market

CHAPEL HILL, N.C., March 24, 2011 /PRNewswire/ -- The pharmaceutical industry has turned to lifecycle planning as one of the strategies to offset lackluster pipelines and patent loss. Fixed dose combination (FDC) products not only offer an opportunity to extend patent life for branded products but also the chance to offer payers and patients a differentiated product with a therapeutic benefit.

Unfortunately, getting to market quickly with an FDC is more myth than reality. On average, it takes between five and eight years to go from decision-to-develop to launch and costs an average of $80 million, according to a new Best Practices, LLC report. Thus, successful FDC products require thoughtful planning, beginning early in the product development and lifecycle management process.

"If you want either to expand an indication or go to a second generation launch, you've got to think about that right when your initial Phase III is done or shortly after you've launched the product that you're going to be including in that fixed dose," one R&D veteran noted in the report.

To identify a potentially successful FDC it's important to understand that commercial success depends on the product offering a differentiated medical benefit, according to "Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market." Focusing on value and differentiated benefit is a critical lesson learned, according to executives working with FDC products.

Some of the issues addressed in this research include:

- Chief reason for pursuing FDC development

- Measures used to evaluate success

- Years from decision to develop through launch

- Cost of FDC product development Approximate

- Difficulty areas for bringing FDC product to market

- Reasons for partnering with another company to develop FDC product

- Time lapsed from initial contact to signed contractual agreement with partner

- U.S. filing routes used

- EU filing routes used

- Months from filing to approval

- Pre-launch marketing challenges

- Specific reimbursement challenges

- Strategies, tactics, practices to help accelerate or impede launch progress

- Lessons learned from executives

- Metrics for effectively communicating business value

The full 55-page report contains more than 150 benchmark metrics, providing executives with the tools, tactics and techniques to help organizations successfully develop and commercialize fixed dose combination products. Review a complimentary summary of the study at The summary includes selected best practices drawn from extensive primary research with 51 representatives from 34 leading companies, including eight of the Top 20 pharma companies. 


Best Practices, LLC serves 48 of the world's 50 top pharmaceutical companies.  For 17 years, we have conducted work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.  For more information about the company, go to

SOURCE Best Practices, LLC
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