Prashanth R Rikkala, Sidharth Shankar Jha, Debasis Pore, Krishna Madhuri Manda, Nandu Gattu and Sanjeev Kumar Shangary*
Discovering a new drug and developing it to the clinic is a, time-consuming and expensive process. A successfully developed patented drug enjoys market exclusivity which provides an opportunity to recoup the R&D expenses. Market competition with similar drugs from other companies, patent cliff and entry of generics present a threat to revenue generation. Successful pharma companies employ suitable Life Cycle Management (LCM) strategies, timed to expand the clinical utility of the drug and boost the revenues through new market exclusivities. Drug combination is one such strategy adopted to add therapeutic value and enhance the commercial life of a drug. In this article, we review drug combination as a Life Cycle Management (LCM) strategy adopted for the US Food and Drug Administration (FDA) approved drugs. We analysed New Molecular Entity (NME) approved by the FDA in the decade of 2001-2010 in four therapeutic areas of oncology, central nervous system, alimentary canal and metabolism and cardiovascular. The life cycle of these NMEs was tracked till 2019 focusing on fixed dose and free dose combination. We present case studies on sitagliptin and everolimus belonging to therapeutic areas metabolism and oncology, respectively, and critically discuss the life cycle of these two drugs. Through the presentation of the clinical utility and revenue generated for the drug combinations, we provide insights into drug combination as a life cycle management strategy.
