Strategies That Make a Difference

Rx to OTC Switch Assessment for Rx Company


An Rx client was anticipating a serious competitive threat for one of its category-leading brands and wanted to understand whether OTC switch of one or more dosage strengths, before patent expiration, could help defend the brand by generating incremental sales and profit growth.

Key Questions

  • Can we switch our lowest dose OTC and keep the rest of the brand Rx?
  • If so, would this strategy drive sufficient incremental sales and profit to justify the effort?

Our Approach and Output

  • Trained the client team on switch requirements and key considerations, switch process, and relevant case precedent
  • Led the team in scenario planning
  • Developed strategic analysis for key variables, including:
    • Primary obstacles to approval and strategies to overcome them, based on a review of the clinical data, expert interviews, and understanding of switch precedent
    • Market scenarios for volumetric testing and financial modeling, based on competitive insight and review of technology pipeline
    • Alternate positioning platforms vs. competition, for market research
    • OTC partner selection criteria, evaluation and prioritization
  • Provided guidance on specific decision inputs and assumptions, based on NCI analysis and proprietary case files, including:
    • OTC pricing options, taking into account trade, managed care, and competitive insights
    • Revenue potential, including OTC sales curves, Rx-to-OTC usage patterns and user values, potential impact of restricted distribution, and impact of order of entry
    • Expense estimates, including spending for marketing/promotion, pre-approval investment, sales infrastructure and staffing requirements, royalty rates and deal terms for OTC partnering
    • Infrastructure requirements (resources, staffing) for stand-alone commercialization, without an OTC partner


  • Validated switch as a viable growth strategy for the client's brand, based on overall strategic assessment, volumetric research and long-term modeling
    • Decision was made to continue to pursue switch as a lifecycle strategy
    • Supported team in making a compelling case for switch in FDA submissions

Client Feedback

"Looking back, it's a little scary...we didn't know how much we didn't know. I shudder to think how our analysis might have turned out had we not had the benefit of NCI's experience."