Abstract
Drug repurposing, often achieved via the FDA’s 505(b) (2) pathway, is an increasingly popular approach in today’s pharmaceutical environment. Repurposing or “re-innovation” comprises a multitude of techniques, which have resulted in wide-ranging commercial success. This article explores the diverse strategies that have been taken to repurpose drugs, and distinguishes a unifying theme among the most commercially successful examples—the ability to address significant unmet needs. The examples listed in this paper relate to small molecules drugs and certainly not exhaustive, however provide some of the key strategies that have been successful using “re-innovation” pathway.
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Accutane is a registered trademark of Hoffmann-La Roche Limited; Absorica is a registered trademark of Ranbaxy Laboratories Inc.; Lidose is a trademark of Galephar Pharmaceutical Research, Inc.; Jentadueto XR is a registered trademark of Boehringer Ingelheim; Zubsolv is a registered trademark of Orexo US, Inc.; Suboxone is a registered trademark of Indivior (UK) Limited; Ulceris is a registered trademark of Valeant Pharmaceuticals International, Inc.; MMX is a registered trademark of Intel Corp.; Abraxane is a registered trademark of Abraxis BioScience, LLC; Cremophor is a registered trademark of BASF SE; Vimovo is a registered trademark of AstraZeneca UK Limited; Xtampza ER and DETERx are registered trademarks of Collegium Pharmaceutical, Inc.; Bendeka and Treanda are registered trademarks of Cephalon, Inc.; Exparel and DepoFoam are registered trademarks of Pacira Pharmaceuticals, Inc.; Voltaren Gel is a registered trademark of Novartis AG; Doryx MPC is a registered trademark of Mayne Pharmaceuticals; Monodox is the registered trademark of Aqua Pharmaceuticals, LLC; Onzetra is a registered trademark of Avanir Pharmaceuticals, Inc.; Imitrex is a registered trademark of the GlaxoSmithKline group of companies; and Vyvanse is a registered trademark of Shire LLC
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The views and opinions expressed in this article are those of the authors and do not necessarily reflect those of Novartis Pharmaceuticals Corporation or Sandoz Inc.
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Suchak, K., Murray, L.J. Patient-Centric Strategies for Drug Re-innovation. J Pharm Innov 14, 187–193 (2019). https://doi.org/10.1007/s12247-018-9351-z
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DOI: https://doi.org/10.1007/s12247-018-9351-z