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

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

doi:10.3390/ph14080710

Cited by 27 publications

(12 citation statements)

References 97 publications

(135 reference 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%

Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19

Imran

Arora

Asdaq³

et al. 2021

Molecules

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140

152

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The COVID-19 pandemic needs no introduction at present. Only a few treatments are available for this disease, including remdesivir and favipiravir. Accordingly, the pharmaceutical industry is striving to develop new treatments for COVID-19. Molnupiravir, an orally active RdRp inhibitor, is in a phase 3 clinical trial against COVID-19. The objective of this review article is to enlighten the researchers working on COVID-19 about the discovery, recent developments, and patents related to molnupiravir. Molnupiravir was originally developed for the treatment of influenza at Emory University, USA. However, this drug has also demonstrated activity against a variety of viruses, including SARS-CoV-2. Now it is being jointly developed by Emory University, Ridgeback Biotherapeutics, and Merck to treat COVID-19. The published clinical data indicate a good safety profile, tolerability, and oral bioavailability of molnupiravir in humans. The patient-compliant oral dosage form of molnupiravir may hit the market in the first or second quarter of 2022. The patent data of molnupiravir revealed its granted compound patent and process-related patent applications. We also anticipate patent filing related to oral dosage forms, inhalers, and a combination of molnupiravir with marketed drugs like remdesivir, favipiravir, and baricitinib. The current pandemic demands a patient compliant, safe, tolerable, and orally effective COVID-19 treatment. The authors believe that molnupiravir meets these requirements and is a breakthrough COVID-19 treatment.

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Section: Expert Opinionmentioning

confidence: 99%

Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19

Imran

Arora

Asdaq³

et al. 2021

Molecules

Self Cite

140

152

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“…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%

Development of Therapeutic and Prophylactic Zinc Compositions for Use against COVID-19: A Glimpse of the Trends, Inventions, and Patents

et al. 2022

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Zinc is an essential nutrient for human health; it is involved in the catalytic, structural, and regulatory functions of the human cellular system. Different compositions of zinc, as well as its pharmaceutically acceptable salts, are available on the market. Recent studies have demonstrated the role of zinc in combating COVID-19. It has been determined that zinc prevents the entry of SARS-CoV-2 into cells by lowering the expression of ACE-2 receptors and inhibiting the RNA-dependent RNA polymerase of SARS-CoV-2. Zinc also prevents the cytokine storm that takes place after the entry of SARS-CoV-2 into the cell, via its anti-inflammatory activity. The authors believe that no study has yet been published that has reviewed the trends, inventions, and patent literature of zinc compositions to treat/prevent COVID-19. Accordingly, this review has been written in order to fill this gap in the literature. The information about the clinical studies and the published patents/patent applications was retrieved from different databases. This review covers patent literature on zinc compositions up to 31 January 2022. Many important patents/patent applications for zinc-based compositions filed by innovative universities and industries were identified. The patent literature revealed zinc compositions in combination with zinc ionophores, antioxidants, antivirals, antibiotics, hydroxychloroquine, heparin, ivermectin, and copper. Most of these studies were supported by clinical trials. The patent literature supports the potential of zinc and its pharmaceutical compositions as possible treatments for COVID-19. The authors believe that countless zinc-based compositions are still unexplored, and there is an immense opportunity to evaluate a considerable number of the zinc-based compositions for use against COVID-19.

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“…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%

Discovery, Development, Inventions and Patent Review of Fexinidazole: The First All-Oral Therapy for Human African Trypanosomiasis

Imran

Khan²,

Alshammari

et al. 2022

Pharmaceuticals

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Human African trypanosomiasis (HAT or ‘sleeping sickness’) is a neglected tropical disease. If untreated, it is always fatal and leads to death. A few treatments are available for HAT, but most of them require a skilled professional, which increases the financial burden on the patient. Recently, fexinidazole (FEX) has been approved by the European Medicine Agency (EMA) and the United States Food and Drug Administration (USFDA) as the first all-oral therapy for the treatment of stage-1 (hemolymphatic) as well as stage-2 (meningoencephalitic) of HAT. Before the FEX approval, there were separate treatments for stage-1 and stage-2 of HAT. This study reviews the discovery, development timeline, inventions, and patent literature of FEX. It was first approved by EMA and USFDA in 2018 and 2021, respectively. FEX was also added to the World Health Organization’s list of essential drugs in 2019. The patent literature search revealed many types of patents/patent applications (compound, salt, process, method of treatment, drug combinations, and compositions) related to FEX, which have been summarized in this article. The authors foresee a great scope to develop more inventions based on FEX (novel salts, polymorphs, drug conjugates, cyclodextrin complex, etc.) for the treatment of many protozoal diseases (Leishmaniasis and Chagas disease), inflammatory diseases, and other microbial infections. New combinations of FEX with other treatments of HAT may also provide fruitful results. This review might be useful to the scientists working on the HAT and other neglected diseases to develop novel inventions and innovations of therapeutic relevance.

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

Cited by 27 publications

References 97 publications

Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19

Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19

Development of Therapeutic and Prophylactic Zinc Compositions for Use against COVID-19: A Glimpse of the Trends, Inventions, and Patents

Discovery, Development, Inventions and Patent Review of Fexinidazole: The First All-Oral Therapy for Human African Trypanosomiasis

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