Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades

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

doi:10.3390/ph14080710

Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades

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

Chemistry

Research output: Contribution to journal › Article › peer-review

31 Scopus citations

Abstract

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.

Original language	English
Article number	710
Journal	Pharmaceuticals
Volume	14
Issue number	8
DOIs	https://doi.org/10.3390/ph14080710
State	Published - Aug 2021

Keywords

Cancer
Generic product
Inflammation
Patent review
Protein kinase inhibitors
USFDA

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3390/ph14080710

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Imran, M., Asdaq, S. M. B., Khan, S. A., Meenakshi, D. U., Alamri, A. S., Alsanie, W. F., Alhomrani, M., Mohzari, Y., Alrashed, A., Almotairi, M., Alkhaldi, E. H., Alorabi, A. K., Alshrari, A. S., Tauseef, M., Abida, Alaqel, S. I., Alam, O., & Bakht, M. A. (2021). Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades. Pharmaceuticals, 14(8), Article 710. https://doi.org/10.3390/ph14080710

@article{7a8c553657e54edb84af9b3eb639b9d3,

title = "Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades",

abstract = "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.",

keywords = "Cancer, Generic product, Inflammation, Patent review, Protein kinase inhibitors, USFDA",

author = "Mohd Imran and Asdaq, \{Syed Mohammed Basheeruddin\} and Khan, \{Shah Alam\} and Meenakshi, \{Dhanalekshmi Unnikrishnan\} and Alamri, \{Abdulhakeem S.\} and Alsanie, \{Walaa F.\} and Majid Alhomrani and Yahya Mohzari and Ahmed Alrashed and Mohammed Almotairi and Alkhaldi, \{Eman H.\} and Alorabi, \{Abeer K.\} and Alshrari, \{Ahmed Subeh\} and Mohammad Tauseef and Abida and Alaqel, \{Saleh I.\} and Ozair Alam and Bakht, \{Md Afroz\}",

note = "Publisher Copyright: {\textcopyright} 2021 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2021",

month = aug,

doi = "10.3390/ph14080710",

language = "English",

volume = "14",

journal = "Pharmaceuticals",

issn = "1424-8247",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "8",

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Imran, M, Asdaq, SMB, Khan, SA, Meenakshi, DU, Alamri, AS, Alsanie, WF, Alhomrani, M, Mohzari, Y, Alrashed, A, Almotairi, M, Alkhaldi, EH, Alorabi, AK, Alshrari, AS, Tauseef, M, Abida, Alaqel, SI, Alam, O & Bakht, MA 2021, 'Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades', Pharmaceuticals, vol. 14, no. 8, 710. https://doi.org/10.3390/ph14080710

TY - JOUR

T1 - Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades

AU - Imran, Mohd

AU - Asdaq, Syed Mohammed Basheeruddin

AU - Khan, Shah Alam

AU - Meenakshi, Dhanalekshmi Unnikrishnan

AU - Alamri, Abdulhakeem S.

AU - Alsanie, Walaa F.

AU - Alhomrani, Majid

AU - Mohzari, Yahya

AU - Alrashed, Ahmed

AU - Almotairi, Mohammed

AU - Alkhaldi, Eman H.

AU - Alorabi, Abeer K.

AU - Alshrari, Ahmed Subeh

AU - Tauseef, Mohammad

AU - Abida,

AU - Alaqel, Saleh I.

AU - Alam, Ozair

AU - Bakht, Md Afroz

PY - 2021/8

Y1 - 2021/8

N2 - 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.

AB - 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.

KW - Cancer

KW - Generic product

KW - Inflammation

KW - Patent review

KW - Protein kinase inhibitors

KW - USFDA

UR - http://www.scopus.com/inward/record.url?scp=85112037321&partnerID=8YFLogxK

U2 - 10.3390/ph14080710

DO - 10.3390/ph14080710

M3 - Article

AN - SCOPUS:85112037321

SN - 1424-8247

VL - 14

JO - Pharmaceuticals

JF - Pharmaceuticals

IS - 8

M1 - 710

ER -

Innovations and patent trends in the development of USFDA approved protein Kinase inhibitors in the last two decades

Abstract

Keywords

UN SDGs

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