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As of 2016, over 2 million people across the EU5 countries have a diagnosis of schizophrenia. Many of the oral atypical antipsychotic therapies used to treat the symptoms of schizophrenia are generically available. Newer depot formulations of atypical antipsychotics offer the possibility of better patient compliance and adherence to therapy. With a wide variety of atypical antipsychotic therapy options available throughout the EU5 markets, novel atypical antipsychotic therapies will be entering a crowded and highly genericized market. As such, new entrants will need to demonstrate superior efficacy and/or safety and tolerability compared with appropriate active comparators in order to be successful in achieving regulatory approval, attaining premium pricing, and securing favorable formulary placement.

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