Mometasone

In the clinical treatment of allergic and autoimmune inflammatory diseases, glucocorticoid drugs always occupy a core position. As a potent synthetic glucocorticoid containing halogenated groups, mometasone has become a common choice in relevant fields by virtue of its differentiated advantages of low systemic absorption and high local anti-inflammatory activity. Its mechanism of action is to bind to intracellular glucocorticoid receptors, inhibit the release of inflammatory mediators, reduce the synthesis of cytokines, and simultaneously have anti-allergic and anti-proliferative effects, which can effectively relieve symptoms such as redness, swelling, itching and exudation caused by inflammatory reactions. Clinically, it is applicable to the local treatment of skin diseases such as eczema, neurodermatitis, atopic dermatitis and psoriasis, and can also improve the symptoms of allergic rhinitis through nasal dosage forms, with the applicable population covering adults and children who meet the indications.

The global mometasone market size maintains a stable growth trend. The overall market size in 2023 was approximately USD 1.28 billion, with a compound annual growth rate of 4.2% from 2019 to 2023, among which the proportions of topical external dosage forms and nasal dosage forms were 58% and 39% respectively. Driven by the rising prevalence of allergic diseases and the improvement of the standardization of external glucocorticoid medication in the domestic market, the market size in 2023 was approximately RMB 970 million, with a compound annual growth rate of 6.8%. In terms of the competitive landscape, the original research products still dominate the mid-to-high-end market, and the number of applications for domestic generic preparations continues to rise. At present, nearly 20 enterprises have obtained the production approval documents for mometasone-related preparations, and domestic enterprises in the API supply side have gradually realized import substitution.

The original research enterprise of mometasone is Schering-Plough (now affiliated to Merck & Co., Inc.). The trade name of its original research topical cream is "Elocon", and the trade name of its nasal spray is "Nasonex". The core compound patent of mometasone in the United States expired in 2000, and the compound patent in China has also expired. The main dosage forms of the original research include 0.1% concentration cream and 50μg/spray nasal spray. All relevant dosage forms have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, at present, the mometasone APIs of a number of enterprises have completed registration with the CDE with the status of A, which can be used in association with domestic preparation applications. A number of domestic generic mometasone creams and nasal sprays have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the needs of mometasone API development and preparation quality research, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable support for the impurity research and quality control links of R&D and manufacturing enterprises.