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Envisioning an actionable research agenda to facilitate repurposing of off-patent drugs

Repurposing off-patent drugs has long been proposed as a cost-effective and efficient strategy to develop new treatments, but its potential has not been realized. Here, we highlight some of the barriers that underlie this lack of progress and discuss potential strategies to address them.
  1. Christopher P. Austin

    1. National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.

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  2. Bobbie Ann Mount

    1. National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.

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  3. Christine M. Colvis

    1. National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.

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Repurposing drugs can bypass some of the most arduous and time-consuming parts of the drug discovery and development process. While repurposing can occur at any stage of a drug or drug candidate’s life cycle, experience has indicated that the most numerous opportunities, and the most numerous difficulties, lie at the stage when the drug no longer has patent protection1. Such drugs are inexpensive and therefore attractive in an era of intense focus on health-care costs.

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Nature Reviews Drug Discovery 20, 723-724 (2021)

doi: https://doi.org/10.1038/d41573-021-00090-y

Acknowledgements

We are grateful to J. Zigterman and S. Jonson for helpful input on the content of this report.

Disclaimer

The ideas presented here do not represent an official opinion of any US government agency.

References

  1. Austin, C. P. Repurposing challenges: conceptualization of a research agenda. DIA Global Forum 2020 https://globalforum.diaglobal.org/issue/june-2020/repurposing-challenges-conceptualization-of-a-research-agenda/ (2020)

  2. Roin, B. N. Solving the problem of new uses. SSRN http://dx.doi.org/10.2139/ssrn.2337821 (2013).

  3. Pahud, D. et al. A new market access path for repurposed drugs. SSRN http://dx.doi.org/10.2139/ssrn.2437502 (2014).

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Competing Interests

The authors declare no competing interests.

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