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.

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'.