Abstract
The US Food and Drug Administration defines an Rx-to-OTC switch as over-the-counter (OTC) marketing of a drug product that was once a prescription (Rx) drug for the same indication, with the same strength, dose, duration of use, dosage form, population and route of administration. Here, we examine the rationale behind switches, the process of switches and historical case studies of switches in the United States to understand the factors for success and expected future trends.
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Acknowledgements
Special thanks for E. Spoley, Senior Consultant Healthcare Practice, for his contributions to this article.
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Laura Mahecha is an employee of Kline & Co., an international consulting firm that through its Healthcare practice has been evaluating the US OTC and Rx pharmaceutical markets, including Rx to OTC switches, for nearly 40 years. The firm has conducted several proprietary switch analyses and has published many syndicated reports on switches for the industry.
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Mahecha, L. Rx-to-OTC switches: trends and factors underlying success. Nat Rev Drug Discov 5, 380–386 (2006). https://doi.org/10.1038/nrd2028
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DOI: https://doi.org/10.1038/nrd2028
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