PMID- 30563197
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231005
IS  - 1999-4923 (Print)
IS  - 1999-4923 (Electronic)
IS  - 1999-4923 (Linking)
VI  - 10
IP  - 4
DP  - 2018 Dec 6
TI  - A Comprehensive Map of FDA-Approved Pharmaceutical Products.
LID - 10.3390/pharmaceutics10040263 [doi]
LID - 263
AB  - With the increasing research and development (R&D) difficulty of new 
      molecular entities (NMEs), novel drug delivery systems (DDSs) are attracting 
      widespread attention. This review investigated the current distribution of Food 
      and Drug Administration (FDA)-approved pharmaceutical products and evaluated the 
      technical barrier for the entry of generic drugs and highlighted the success and 
      failure of advanced drug delivery systems. According to the ratio of generic to 
      new drugs and the four-quadrant classification scheme for evaluating the 
      commercialization potential of DDSs, the results showed that the traditional 
      dosage forms (e.g., conventional tablets, capsules and injections) with a lower 
      technology barrier were easier to reproduce, while advanced drug delivery systems 
      (e.g., inhalations and nanomedicines) with highly technical barriers had less 
      competition and greater market potential. Our study provides a comprehensive 
      insight into FDA-approved products and deep analysis of the technical barriers 
      for advanced drug delivery systems. In the future, the R&D of new molecular 
      entities may combine advanced delivery technologies to make drug candidates into 
      more therapeutically effective formulations.
FAU - Zhong, Hao
AU  - Zhong H
AD  - State Key Laboratory of Quality Research in Chinese Medicine, Institute of 
      Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China. 
      MB75822@umac.mo.
FAU - Chan, Ging
AU  - Chan G
AD  - State Key Laboratory of Quality Research in Chinese Medicine, Institute of 
      Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China. 
      Gchan@umac.mo.
FAU - Hu, Yuanjia
AU  - Hu Y
AD  - State Key Laboratory of Quality Research in Chinese Medicine, Institute of 
      Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China. 
      YuanjiaHu@umac.mo.
FAU - Hu, Hao
AU  - Hu H
AUID- ORCID: 0000-0001-9441-106X
AD  - State Key Laboratory of Quality Research in Chinese Medicine, Institute of 
      Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China. 
      Haohu@umac.mo.
FAU - Ouyang, Defang
AU  - Ouyang D
AD  - State Key Laboratory of Quality Research in Chinese Medicine, Institute of 
      Chinese Medical Sciences (ICMS), University of Macau, Macau 999078, China. 
      defangouyang@umac.mo.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20181206
PL  - Switzerland
TA  - Pharmaceutics
JT  - Pharmaceutics
JID - 101534003
PMC - PMC6321070
OTO - NOTNLM
OT  - FDA-approval drugs
OT  - complex injection
OT  - drug delivery system
OT  - generic drugs
OT  - inhalation
OT  - oral sustained-release preparation
OT  - transdermal patch
COIS- The authors declare no conflict of interest.
EDAT- 2018/12/20 06:00
MHDA- 2018/12/20 06:01
PMCR- 2018/12/01
CRDT- 2018/12/20 06:00
PHST- 2018/11/06 00:00 [received]
PHST- 2018/11/28 00:00 [revised]
PHST- 2018/11/30 00:00 [accepted]
PHST- 2018/12/20 06:00 [entrez]
PHST- 2018/12/20 06:00 [pubmed]
PHST- 2018/12/20 06:01 [medline]
PHST- 2018/12/01 00:00 [pmc-release]
AID - pharmaceutics10040263 [pii]
AID - pharmaceutics-10-00263 [pii]
AID - 10.3390/pharmaceutics10040263 [doi]
PST - epublish
SO  - Pharmaceutics. 2018 Dec 6;10(4):263. doi: 10.3390/pharmaceutics10040263.