An overview of FDA-approved new molecular entities: 1827–2013
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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Development of new classes of drugs for the treatment of hypertension has remained steady over the same time period as the limited development of anxiety drugs.
“By comparison, development of new classes of drugs for the treatment of hypertension has remained steady over the same time period18 (Fig. 1).”
From Resolving the neural circuits of anxiety (2015) · cites this paper as [18]
Since the 1950s, new molecular entities approved by the FDA with primary indications for anxiety have been limited to benzodiazepines and the atypical anxiolytics buspirone, meprobamate and hydroxyzine pamoate.
“Since the 1950s, new molecular entities approved by the US Food and Drug Administration (FDA) with primary indications for anxiety have been limited to benzodiazepines and the atypical anxiolytics buspirone, meprobamate and hydroxyzine pamoate18.”
From Resolving the neural circuits of anxiety (2015) · cites this paper as [18]
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- Authors
- Kinch, M. S., Haynesworth, A., Kinch, S. L., & Hoyer, D.
- Affiliations
- Yale University (US)
- Corresponding author
- Kinch, Michael S.
- Venue
- Drug Discovery Today
- Publisher
- Elsevier BV
- Published
- 2014-08
- Volume
- 19
- Issue
- 8
- Pages
- 1033-1039
- ISSN
- 1359-6446 (ISSN-L)
- 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
- Locations
- Drug Discovery Today (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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