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Effectively Bringing Fixed Dose Combination Products to Market to Maintain Growth and Pipelines

CHAPEL HILL, N.C., March 8, 2013 /PRNewswire/ -- The pharmaceutical industry has turned to sustainable growth opportunities to address the pipeline and patent challenges facing many organizations in the sector. One opportunity for growth lies in extending a product's patent life by combining branded products.

Fixed dose combination (FDC) products have clinical and commercial advantages. For the drug manufacturer, an FDC product can extend the therapeutic advantage and becomes part of lifecycle management. For the patient, FDC products can address unmet medical needs and reduce pill burdens.

But there is more to success than just developing a new FDC and launching it. Successful research and development leaders recognize that understanding the market and audience will smooth the FDC launch process, according to a study by benchmarking leader Best Practices, LLC.

"Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market" identifies successful strategies and innovative practices for developing and bringing FDC products to market. Through executive insights and advice, the study also addresses the pitfalls and obstacles to avoid in this work.

A third of the FDC leaders who participated in the study said the most important lesson learned from their work with FDC products is the need to focus on the differentiated benefit and value that the product can bring to patients, physicians and payers.

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
  • Time lapsed from initial contact to signed contractual agreement with partner
  • U.S. filing routes used
  • EU filing routes used
  • 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 is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations. Best Practices, LLC believes in the 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.


SOURCE Best Practices, LLC
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