General practitioner practice-based pharmacist input to medicines optimisation in the UK: pragmatic, multicenter, randomised, controlled trial

• Drug repurposing is fnding novel uses for existing drugs. • Indication-specifc market exclusivities have been used to incentivize drug innovators to conduct the clinical trials preferred by drug regulators for label changes, but these are difcult to enforce because generic equivalents may still be approved and used of-label. • Our study fnds that, despite indication-specifc exclusivities, no new indications are added after FDA approval for two-thirds of drugs and that the probability of new indication additions drops to near zero after generic entry occurs. • As status quo for most drug innovators appears is creating novel one-indication products, there is much room for improving incentivizes for clinical investigations for new uses and for maximizing existing medicines’ full therapeutic potential. 

• Drug repurposing is fnding novel uses for existing drugs. • Indication-specifc market exclusivities have been used to incentivize drug innovators to conduct the clinical trials preferred by drug regulators for label changes, but these are difcult to enforce because generic equivalents may still be approved and used of-label. • Our study fnds that, despite indication-specifc exclusivities, no new indications are added after FDA approval for two-thirds of drugs and that the probability of new indication additions drops to near zero after generic entry occurs. • As status quo for most drug innovators appears is creating novel one-indication products, there is much room for improving incentivizes for clinical investigations for new uses and for maximizing existing medicines’ full therapeutic potential.