An overview of FDA-approved new molecular entities: 1827-2013

Michael S. Kinch, Austin Haynesworth, Sarah L. Kinch, Denton Hoyer

Research output: Contribution to journalShort surveypeer-review

157 Scopus citations


The pharmaceutical industry is undergoing fundamental change and its future is unclear. We performed a meta-analysis by cataloging FDA-approved legacy drugs and new molecular entities (NMEs). Objective information regarding scientific, medical and commercial activities was captured and provides insight into processes governing drug development. In this report, we review the rates of NME introduction through to the end of 2013. Recent trends show the emergence of a handful of companies that controls two-thirds of NMEs. We also report growth in the number of NMEs controlled by marketing organizations that have little or no internal drug discovery or development activities. This trend has increased dramatically since 2000 and could raise important questions about the future landscape and viability of drug discovery and development.

Original languageEnglish
Pages (from-to)1033-1039
Number of pages7
JournalDrug Discovery Today
Issue number8
StatePublished - Aug 2014


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