Off-Patent drug repositioning
Abstract
Drug repositioning aims to reuse "old" drugs to treat diseases outside their approved indication(s). Composition-of-matter patents and FDA exclusivities can hinder the immediate availability of some drugs to be repositioned (repurposed). Here, we analyze data from the FDA Orange Book and use current on-market patent validity and exclusivities to classify drugs into on-patent (ONP), off-patent (OFP), and off-market (OFM) sets. In the absence of an unanimously accepted definition for small molecules, these sets include organic molecules and peptides with molecular weight between 100 and 1250, which resulted in 237 ONP drugs, 320 OFM, and 996 OFP drugs, respectively. We discuss the differences between the three categories in terms of primary molecular properties, chemical diversity, mechanism-of-action target classes, and therapeutic areas and comment on the enrichment of OFP drugs in the near future. Given the intellectual property landscape, and in the absence of specific property rights, we suggest that drugs should be prioritized as follows, to improve the repositioning strategy: (i) OFP, (ii) OFM, and (iii) ONP, respectively.
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The 2023 DrugCentral database contains off-patent tags for 1712 drugs, a 10% increase compared to 2021.
“The 2023 DrugCentral database contains off-patent tags for 1712 drugs, a 10% increase in drug annotations compared to 2021 (24).”
From DrugCentral 2023 extends human clinical data and integrates veterinary drugs (2023) · cites this paper as [24]
There are 166 drugs mapped into the off-patent schema: 119 OFP, 46 OFM, and only one ONP.
“There are 166 drugs mapped into the off-patent schema (24) as follows: 119 OFP, 46 OFM, and only one ONP.”
From DrugCentral 2023 extends human clinical data and integrates veterinary drugs (2023) · cites this paper as [24]
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- Authors
- Avram, S., Curpan, R., Halip, L., Bora, A., & Oprea, T. I.
- Affiliations
- Romanian Academy (RO)
- University of Copenhagen (DK)
- Corresponding author
- Oprea, Tudor I.
- Venue
- Journal of Chemical Information and Modeling
- Publisher
- American Chemical Society (ACS)
- Published
- 2020-09-02
- Volume
- 60
- Issue
- 12
- Pages
- 5746-5753
- ISSN
- 1549-9596 (ISSN-L)
- 1549-960X
- OpenAlex
- W3082453120
- Cited by
- 18
- References
- 26
- Citations by year
- 2025: 3 · 2024: 2 · 2023: 4 · 2022: 6 · 2021: 1 · 2020: 2
- FWCI
- 1.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Journal of Chemical Information and Modeling (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Funders
- NIH Office of the Director (U24 CA224370)
- Topics
- Physical Sciences › Computer Science › Computational Theory and Mathematics › Computational Drug Discovery Methods
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Business, Management and Accounting › Management of Technology and Innovation › Intellectual Property and Patents
- Keywords
- drug repurposing, off-patent drugs, patent validity, FDA Orange Book, small molecules, chemical diversity, mechanism of action, therapeutic areas, intellectual property, drug prioritization
- MeSH terms
- Drug Repositioning
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