Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades

Protein kinase inhibitors (PKIs) are important therapeutic agents. As of 31 May 2021, the United States Food and Drug Administration (USFDA) has approved 70 PKIs. Most of the PKIs are employed to treat cancer and inflammatory diseases. Imatinib was the first PKI approved by USFDA in 2001. This revie...

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Main Authors: Mohd. Imran, Syed Mohammed Basheeruddin Asdaq, Shah Alam Khan, Dhanalekshmi Unnikrishnan Meenakshi, Abdulhakeem S. Alamri, Walaa F. Alsanie, Majid Alhomrani, Yahya Mohzari, Ahmed Alrashed, Mohammed AlMotairi, Eman H. Alkhaldi, Abeer K. Alorabi, Ahmed Subeh Alshrari, Mohammad Tauseef, Abida, Saleh I. Alaqel, Ozair Alam, Md. Afroz Bakht
Format: Article
Language:English
Published: MDPI AG 2021-07-01
Series:Pharmaceuticals
Subjects:
Online Access:https://www.mdpi.com/1424-8247/14/8/710
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spelling doaj-042149ad6a3b48718874cc85daad41772021-08-26T14:12:05ZengMDPI AGPharmaceuticals1424-82472021-07-011471071010.3390/ph14080710Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two DecadesMohd. Imran0Syed Mohammed Basheeruddin Asdaq1Shah Alam Khan2Dhanalekshmi Unnikrishnan Meenakshi3Abdulhakeem S. Alamri4Walaa F. Alsanie5Majid Alhomrani6Yahya Mohzari7Ahmed Alrashed8Mohammed AlMotairi9Eman H. Alkhaldi10Abeer K. Alorabi11Ahmed Subeh Alshrari12Mohammad Tauseef13Abida14Saleh I. Alaqel15Ozair Alam16Md. Afroz Bakht17Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Northern Border University, Arar 91911, Saudi ArabiaDepartment of Pharmacy Practice, College of Pharmacy, AlMaarefa University, Dariyah, Riyadh 13713, Saudi ArabiaCollege of Pharmacy, National University of Science and Technology, Muscat 130, OmanCollege of Pharmacy, National University of Science and Technology, Muscat 130, OmanDepartment of Clinical Laboratory Sciences, The Faculty of Applied Medical Sciences, Taif University, Taif 21944, Saudi ArabiaDepartment of Clinical Laboratory Sciences, The Faculty of Applied Medical Sciences, Taif University, Taif 21944, Saudi ArabiaDepartment of Clinical Laboratory Sciences, The Faculty of Applied Medical Sciences, Taif University, Taif 21944, Saudi ArabiaClinical Pharmacy Department, King Saud Medical City, Riyadh 12746, Saudi ArabiaPharmaceutical Services Administration, Inpatient Department, Main Hospital, King Fahad Medical City, Riyadh 11564, Saudi ArabiaDepartment of Clinical Pharmacy, King Fahad Medical City, Riyadh 11564, Saudi ArabiaPharmaceutical Care Services, King Saud Medical City, Riyadh 12746, Saudi ArabiaPharmaceutical Care Services, King Salman Specialist Hospital, Hail 55471, Saudi ArabiaDepartment of Biological Sciences, Faculty of Science, Northern Border University, Arar 91431, Saudi ArabiaDepartment of Pharmaceutical Sciences, College of Pharmacy, Chicago States University, Chicago, IL 60607, USADepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Northern Border University, Arar 91911, Saudi ArabiaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Northern Border University, Arar 91911, Saudi ArabiaMedicinal Chemistry and Molecular Modelling Lab., Department of Pharmaceutical Chemistry, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, IndiaDepartment of Chemistry, College of Science and Humanities, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaProtein kinase inhibitors (PKIs) are important therapeutic agents. As of 31 May 2021, the United States Food and Drug Administration (USFDA) has approved 70 PKIs. Most of the PKIs are employed to treat cancer and inflammatory diseases. Imatinib was the first PKI approved by USFDA in 2001. This review summarizes the compound patents and the essential polymorph patents of the PKIs approved by the USFDA from 2001 to 31 May 2021. The dates on the generic drug availability of the PKIs in the USA market have also been forecasted. It is expected that 19 and 48 PKIs will be genericized by 2025 and 2030, respectively, due to their compound patent expiry. This may reduce the financial toxicity associated with the existing PKIs. There are nearly 535 reported PKs. However, the USFDA approved PKIs target only about 10–15% of the total said PKs. As a result, there are still a large number of unexplored PKs. As the field advances during the next 20 years, one can anticipate that PKIs with many scaffolds, chemotypes, and pharmacophores will be developed.https://www.mdpi.com/1424-8247/14/8/710protein kinase inhibitorsUSFDAcancerinflammationpatent reviewgeneric product
collection DOAJ
language English
format Article
sources DOAJ
author Mohd. Imran
Syed Mohammed Basheeruddin Asdaq
Shah Alam Khan
Dhanalekshmi Unnikrishnan Meenakshi
Abdulhakeem S. Alamri
Walaa F. Alsanie
Majid Alhomrani
Yahya Mohzari
Ahmed Alrashed
Mohammed AlMotairi
Eman H. Alkhaldi
Abeer K. Alorabi
Ahmed Subeh Alshrari
Mohammad Tauseef
Abida
Saleh I. Alaqel
Ozair Alam
Md. Afroz Bakht
spellingShingle Mohd. Imran
Syed Mohammed Basheeruddin Asdaq
Shah Alam Khan
Dhanalekshmi Unnikrishnan Meenakshi
Abdulhakeem S. Alamri
Walaa F. Alsanie
Majid Alhomrani
Yahya Mohzari
Ahmed Alrashed
Mohammed AlMotairi
Eman H. Alkhaldi
Abeer K. Alorabi
Ahmed Subeh Alshrari
Mohammad Tauseef
Abida
Saleh I. Alaqel
Ozair Alam
Md. Afroz Bakht
Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
Pharmaceuticals
protein kinase inhibitors
USFDA
cancer
inflammation
patent review
generic product
author_facet Mohd. Imran
Syed Mohammed Basheeruddin Asdaq
Shah Alam Khan
Dhanalekshmi Unnikrishnan Meenakshi
Abdulhakeem S. Alamri
Walaa F. Alsanie
Majid Alhomrani
Yahya Mohzari
Ahmed Alrashed
Mohammed AlMotairi
Eman H. Alkhaldi
Abeer K. Alorabi
Ahmed Subeh Alshrari
Mohammad Tauseef
Abida
Saleh I. Alaqel
Ozair Alam
Md. Afroz Bakht
author_sort Mohd. Imran
title Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
title_short Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
title_full Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
title_fullStr Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
title_full_unstemmed Innovations and Patent Trends in the Development of USFDA Approved Protein Kinase Inhibitors in the Last Two Decades
title_sort innovations and patent trends in the development of usfda approved protein kinase inhibitors in the last two decades
publisher MDPI AG
series Pharmaceuticals
issn 1424-8247
publishDate 2021-07-01
description Protein kinase inhibitors (PKIs) are important therapeutic agents. As of 31 May 2021, the United States Food and Drug Administration (USFDA) has approved 70 PKIs. Most of the PKIs are employed to treat cancer and inflammatory diseases. Imatinib was the first PKI approved by USFDA in 2001. This review summarizes the compound patents and the essential polymorph patents of the PKIs approved by the USFDA from 2001 to 31 May 2021. The dates on the generic drug availability of the PKIs in the USA market have also been forecasted. It is expected that 19 and 48 PKIs will be genericized by 2025 and 2030, respectively, due to their compound patent expiry. This may reduce the financial toxicity associated with the existing PKIs. There are nearly 535 reported PKs. However, the USFDA approved PKIs target only about 10–15% of the total said PKs. As a result, there are still a large number of unexplored PKs. As the field advances during the next 20 years, one can anticipate that PKIs with many scaffolds, chemotypes, and pharmacophores will be developed.
topic protein kinase inhibitors
USFDA
cancer
inflammation
patent review
generic product
url https://www.mdpi.com/1424-8247/14/8/710
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