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

Kinch, Michael S., Haynesworth, Austin, Kinch, Sarah L., Hoyer, Denton·2014·Drug Discovery Today

DOI 10.1016/j.drudis.2014.03.018

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Abstract

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.

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Authors: Kinch, M. S., Haynesworth, A., Kinch, S. L., & Hoyer, D.
Affiliations: Yale University (US)
Corresponding author: Kinch, Michael S.
ORCID: Kinch, Michael S.
Haynesworth, Austin
Hoyer, Denton
Venue: Drug Discovery Today
Publisher: Elsevier BV
Published: 2014-08
Volume: 19
Issue: 8
Pages: 1033-1039
ISSN: 1359-6446 (ISSN-L)
DOI: 10.1016/j.drudis.2014.03.018
OpenAlex: W2046088696
Cited by: 210
References: 7
Citations by year: 2026: 4 · 2025: 6 · 2024: 5 · 2023: 17 · 2022: 12 · 2021: 15 · 2020: 22 · 2019: 24 · 2018: 25 · 2017: 28 · 2016: 22 · 2015: 22 · 2014: 8
FWCI: 66.12
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Drug Discovery Today (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Firm Innovation and Growth
Keywords: new chemical entities, FDA-approved drugs, drug development trends, pharmaceutical industry consolidation, drug discovery, pharmaceutical companies, marketing organization, drug approval rates
MeSH terms: Drug Industry, Time Factors, United States, United States Food and Drug Administration, Drug Approval, Drug Discovery

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

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