2021
DOI: 10.3390/ph14080710
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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 be… Show more

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Cited by 29 publications
(17 citation statements)
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“…The compound patent of molnupiravir has been granted by the USPTO [ 29 ] with an estimated expiry date of 7 December 2038. The USPTO provides up to 5 years’ extension to drug patents [ 59 ]. If molnupiravir is approved by the USFDA then the expiry date of the compound patent of molnupiravir [ 29 ] may also be extended beyond 7 December 2038.…”
Section: Expert Opinionmentioning
confidence: 99%
“…The compound patent of molnupiravir has been granted by the USPTO [ 29 ] with an estimated expiry date of 7 December 2038. The USPTO provides up to 5 years’ extension to drug patents [ 59 ]. If molnupiravir is approved by the USFDA then the expiry date of the compound patent of molnupiravir [ 29 ] may also be extended beyond 7 December 2038.…”
Section: Expert Opinionmentioning
confidence: 99%
“…The compound patent of FEX [21] has expired long ago and is also not listed in the orange book of the USFDA [52,53]. Since this patent has expired, it is not eligible for any patent term extension [54,55]. Accordingly, we trust that the generic entry in the USA will be after the expiry of the orphan drug exclusivity (16 July 2028) (Table 2).…”
Section: Expert Opinionmentioning
confidence: 99%
“…The patent exploration was carried out utilizing different patent databases (Sci-Finder, Espacenet, Patentscope, and the USPTO) [ 34 , 35 , 36 , 37 , 38 , 39 , 40 ] on 31 January 2022. A combination search for the terms “Zinc + COVID-19” and “Zinc + SARS-CoV-2” was performed in different fields (claims, abstract, and title) of Espacenet, Patentscope, and the USPTO.…”
Section: Patent Searchingmentioning
confidence: 99%