Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications

Jonathan Brett^{1

2}, Dilara Bahceci³, Wendy Lipworth⁴, Paul Liknaitzky^{5

6}, Ric O Day¹, Anthony Rodgers³

Affiliations

¹ Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
² Medicines Intelligence Centre for Research Excellence, University of New South Wales, Sydney, New South Wales, Australia.
³ The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
⁴ Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia.
⁵ Department of Psychiatry, School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia.
⁶ Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia.

PMID: 37409815
PMCID: PMC10947264
DOI: 10.1111/imj.16159

Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications

Jonathan Brett et al. Intern Med J. 2023 Jul.

. 2023 Jul;53(7):1284-1287.

doi: 10.1111/imj.16159. Epub 2023 Jul 6.

Authors

Jonathan Brett^{1

2}, Dilara Bahceci³, Wendy Lipworth⁴, Paul Liknaitzky^{5

6}, Ric O Day¹, Anthony Rodgers³

Affiliations

¹ Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
² Medicines Intelligence Centre for Research Excellence, University of New South Wales, Sydney, New South Wales, Australia.
³ The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
⁴ Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia.
⁵ Department of Psychiatry, School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia.
⁶ Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia.

PMID: 37409815
PMCID: PMC10947264
DOI: 10.1111/imj.16159

Abstract

With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.

Keywords: generic; medicine; off-label; off-patent; repurposing.

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Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications

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Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications

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