Strategic balance of drug lifecycle management options differs between domestic and foreign companies in Japan.

INTRODUCTION: Drug approvals and patent protections are critical in drug lifecycle management (LCM) in order to maximize drug discovery investment returns. AREA COVERED: We analyzed drug LCM activities implemented by 10 top companies in Japan, focusing on drug approvals and patent term extensions. EXPERT OPINION: Foreign companies acquired numerous drug approvals primarily for new molecular entities (NMEs), while Japanese companies mainly obtained approvals for improved drugs including new indications, and intensively extended patent terms. Furthermore, we discovered three factors likely responsible for differences in drug LCM strategies of Japanese and foreign companies: research and development capacities for drugs, drug lags of foreign-origin NMEs, and cooperation between Research and Development Departments and Intellectual Property Departments.