OBJECTIVES: 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. METHODS: Off-patent (branded and unbranded) drug consumption and expenditure indicators from 2004 (first year in which net expenditure was available) to 2013 (last available year) were analysed from the Observatory on the Use of Medicines (OSMED) published reports. RESULTS: In 2004 consumption by defined daily dose (DDD) per 1,000 habitants was 166.8 (21.7% on total DDD), while in 2013, it was 663.0 (64.3% on total DDD) for territorial drugs. Per-capita expenditure was €22 (10.1% of net territorial expenditures) in 2004 and €62.4 in 2013 (41.5% of net territorial expenditure). Such results were mainly due to the higher number of off-patent drugs available on the market and not only to increased use of generic drugs. In 2004, the percentage of unbranded drugs was 1.9% and raised until 14.9% in 2013. Despite such growth, Italy was in 2013 the third European country (behind Greece and Ireland) for expenditure on branded drugs, with a very low uptake vs Germany, France, Spain and UK showing an incidence of generic territorial drug expenditure between 30 and 40%. CONCLUSIONS: Consumption and expenditure on off-patent drugs has increased in the last 10 years in Italy, however the unbranded drugs uptake is still very low when compared with other European countries.