Molnupiravir

The clinical application of small-molecule oral COVID-19 drugs provides a key intervention measure to reduce the risk of severe illness in high-risk groups. As the first approved oral RNA polymerase inhibitor anti-SARS-CoV-2 drug, molnupiravir exerts its antiviral effect by inducing lethal mutations during viral RNA replication, and it can take effect without metabolic activation in vivo. This drug is indicated for the treatment of adult patients with mild to moderate novel coronavirus infection who have risk factors for progression to severe illness, including the elderly, obese people, people with chronic underlying diseases, people with immunodeficiency, etc., and it can significantly reduce the risk of hospitalization or death in unvaccinated high-risk groups.

The global oral anti-COVID-19 drug market still maintains stable demand in the stage of normalized epidemic prevention and control, and the global sales of molnupiravir in 2023 were approximately USD 1.18 billion. Due to the continuous mutation of SARS-CoV-2 strains, this drug is still listed as a recommended drug by multiple international guidelines. In terms of the domestic market, a number of pharmaceutical companies have currently submitted marketing applications for generic molnupiravir. As the expiration of the original research patent is approaching, the launch of generic versions in the future will further improve the accessibility of the drug, and market competition will focus on cost control and supply chain stability.

The original research enterprise of molnupiravir is Merck & Co., Inc., and the original brand name is LAGEVRIO. The expiration time of its core compound patent in major global markets is 2029. The domestically approved original formulation is capsules with a specification of 0.2g, which has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. At present, more than 10 domestic enterprises have submitted CDE registration applications for molnupiravir API, among which the API registration status of multiple enterprises is A, which can support the marketing declaration of domestic generic drugs. (Data as of June 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for molnupiravir API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable technical support for pharmaceutical enterprises in API R&D, quality research and generic drug declaration.