OBJECTIVES In Europe, orphan designation has been granted by European Medicines Agency since 2000. Molecules with orphan designation can benefit from a number of incentives to guarantee return on investment for manufacturers. Since introduction of orphan legislation, the number of Orphan Drugs (OD) has significantly increased. In 2012, total OD sales reached 13% of the whole pharmaceutical market. This study aims to analyse current situation and trends in OD approvals. METHODS All ODs approved gaining marketing authorization was identified through EMA website. Extensions to a new disease were considered as an independent approval, while extensions of indication for the same condition were not considered. Information on drug status, indications, therapeutic area, and authorisation date was extracted. RESULTS