Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Consulting; Biopharmaceutical


Companies Profiled:
Abbott; Xanodyne Pharmaceuticals; Victory; Valeant; Solvay Pharmaceuticals; Shire; Sanofi-aventis; Sandoz; PLIVA Pharmaceuticals; Pfizer; Patheon; Noven Therapeuticals; Novartis; Merck; GlaxoSmithKline; Genzyme; IMS; Forest Laboratories; Inc; Elixir Pharmaceuticals; Eisai; Daiichi Sankyo; Catalent Pharma Solutions; Boehringer Ingelheim; Bristol-Myers Squibb

Study Snapshot

Primary research was conducted through an online survey instrument and in-depth interviews. Fifty-one representatives from 34 biopharmaceutical companies participated in this primary research. From seasoned executives to innovative managers, the range of respondent titles reflects depth and breadth of perspective in developing and/or commercializing FDC products. Respondents have an average of nearly 10 years of experience in working with FDCs. Eighty-four percent of respondents currently manage activities that involve FDC products.

Sample Key Findings

Less than a third of respondents said they partnered with another pharmaceutical company to develop the FDC

• Most successful FDCs are developed by a single company, using its own assets and resources. Less than a third of respondents said they partnered with another pharmaceutical company to develop the FDC

• Key Insights
• Detailed Findings
• Appendix

• Success of the FDC effort so far
• Important measures used to evaluate success
• Years from decision to develop through first development activity
• Years from first development activity through final formulation
• Years from final formulation through launch
• Approximate cost of development of FDC product
• Difficulty areas for bringing FDC product to market
• % partnering with another pharmaceutical company
• Reasons for partnering with another company to develop FDC product
• Time lapsed from initial contact to signed contractual agreement with partner
• Summary basis of approval for FDC product
• Application locations for registration of the drug product
• US filing routes used
• EU filing routes used
• Months from filing to approval
• Differentiating or enabling drug delivery technology used
• Use of third party vendor for development
• use of third party vendor to produce launch or material supplies
• Patent applications and approvals
• Market exclusivity achieved
• Preclinical toxicity or safety testing done to support registration
• Pre-launch marketing challenges
• Specific reimbursement challenges
• Strategies, tactics, practices to help accelerate or impede launch progress
• Lessons learned from executives