Drug repositioning and repurposing: terminology and definitions in literature

Drug repositioning and similar terms have been a trending topic in literature and represent novel drug development strategies. We analysed in a quantitative and qualitative manner how these terms were used and defined in the literature. In total, 217 articles referred to 'drug repositioning', 'drug repurposing', 'drug reprofiling', 'drug redirecting' and/or 'drug rediscovery'. Only 67 included a definition ranging from brief and general to extensive and specific. No common definition was identified. Nevertheless, four common features were found: concept, action, use and product. The different wording used for these features often leads to essential differences in meaning between definitions. In case a clear definition is needed, for example from a legal or regulatory perspective, the features can provide further guidance

Extensions of indication throughout the drug product lifecycle: a quantitative analysis

The marketing authorisation of the first generic product version is an important moment in a drug product lifecycle. The subsequently changed intellectual property protection prospects could affect the incentives for further drug development. We assessed the quantity and nature of extensions of indication of small molecule medicinal products authorised through the European Medicines Agency throughout the drug product lifecycle with special attention for the impact of the introduction of a first generic competitor. The majority (92.5%) of the extensions of indication was approved during the exclusivity period of the innovator product. Regulatory rethinking might be needed for a sustainable stimulation of extensions of indications in the post-generic period of a drug product lifecycle

Extensions of indication throughout the drug product lifecycle: a quantitative analysis

The marketing authorisation of the first generic product version is an important moment in a drug product lifecycle. The subsequently changed intellectual property protection prospects could affect the incentives for further drug development. We assessed the quantity and nature of extensions of indication of small molecule medicinal products authorised through the European Medicines Agency throughout the drug product lifecycle with special attention for the impact of the introduction of a first generic competitor. The majority (92.5%) of the extensions of indication was approved during the exclusivity period of the innovator product. Regulatory rethinking might be needed for a sustainable stimulation of extensions of indications in the post-generic period of a drug product lifecycle

Drug repositioning and repurposing: terminology and definitions in literature

Drug repositioning and similar terms have been a trending topic in literature and represent novel drug development strategies. We analysed in a quantitative and qualitative manner how these terms were used and defined in the literature. In total, 217 articles referred to 'drug repositioning', 'drug repurposing', 'drug reprofiling', 'drug redirecting' and/or 'drug rediscovery'. Only 67 included a definition ranging from brief and general to extensive and specific. No common definition was identified. Nevertheless, four common features were found: concept, action, use and product. The different wording used for these features often leads to essential differences in meaning between definitions. In case a clear definition is needed, for example from a legal or regulatory perspective, the features can provide further guidance