As in most European countries, spending on pharmaceuticals has also been cut in recent years in Italy through a series of measures, including price reduction and boosting of off-patent drugs prescription. Laws 338/2000 and 405/2001 incentivised the use of generic drugs and introduced patients’ co-payment if they preferred a branded vs off-patent drug. The aim of this study was to analyse the consumption and expenditure trend for off-patent drugs in Italy since the introduction of these new measures.