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

Abstract

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.

Efficacy and safety of three new oral antiviral treatment (molnupiravir, fluvoxamine and Paxlovid) for COVID-19：a meta-analysis

“…However, studies have shown that even vaccinated people are infected with novel coronavirus variants. Millions of immunocompromised patients may not be fully protected after vaccination, and existing vaccines may not be effective against new novel coronavirus variants [ 4 , 5 ]. Although an antiviral drug Remdesivir has been developed that has shown good effects in antiviral therapy [ 6 ], some clinical trials have not fully demonstrated its beneficial effects on SARS-COV-2; moreover, the drug is expensive and must be administered intravenously in a hospital setting [ 6–8 ].…”

Races of small molecule clinical trials for the treatment of COVID‐19: An up‐to‐date comprehensive review

“…Especifically, molnupiravir (aka EIDD‐2801 and MK‐4482) induced RNA mutagenesis by the viral RNA‐dependent RdRp. Molnupiravir showed an exciting experimental results in phase 2 clinical trials, and was one of the most promising small molecule anti‐coronavirus drugs at present (Imran et al, 2021 ; Kabinger & Stiller, 2021 ; Malone & Campbell, 2021 ). In October 2021, Merck Co. submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir based on the promising results from the Phase 3 MOVeOUT clinical trial (Press releas, Merck Company website, 2021).…”

Discovery, Development, Inventions, and Patent Trends on Mobocertinib Succinate: The First-in-Class Oral Treatment for NSCLC with EGFR Exon 20 Insertions

“…Different types of patents are possible for a pharmaceutical compound including patents claiming compound, salt, isomer, polymorph, process, intermediate used in the process, drug impurity, method of treatment, different dosage forms, particle size, and drug combinations [ 70 , 71 , 72 , 73 ]. The types of patents/patent applications related to mobocertinib are mentioned in Figure 7 .…”

“…In early 2017, Takeda acquired Ariad Pharmaceuticals and became the owner of the patents filed by Ariad Pharmaceuticals. These two patents are eligible for patent term extension up to five years [ 70 , 71 , 72 , 73 ]. If this happens, these patents will expire by 2040.…”