Desloratadine

As one of the chronic diseases with high global incidence, allergic diseases have long had a rigid clinical demand for highly effective antihistamines with low sedative effects. Desloratadine is a second-generation non-sedative tricyclic antihistamine and the active metabolite of loratadine. It can selectively block peripheral H1 receptors and inhibit the release of histamine and other inflammatory mediators, effectively relieving symptoms of allergic rhinitis such as sneezing, runny nose, nasal itching, nasal congestion, as well as symptoms of chronic idiopathic urticaria such as skin itching and wheals. It has no obvious central sedative effect, and can be safely used by adults and adolescents over 12 years old. Some of its indications also cover children over 6 months old, making it a first-line drug for the treatment of allergic diseases.

At present, the global desloratadine market size is stable at around USD 1.5 billion, with a compound annual growth rate of approximately 3.2%. The domestic market size has exceeded RMB 1.8 billion, and its market share in the retail segment of antihistamines has ranked among the top three for five consecutive years. After the arrival of the patent cliff, the generic drug market has expanded rapidly. At present, there are more than 70 approved product specifications of desloratadine preparations in China, and the price reduction of winning bids in centralized procurement has exceeded 80%. The demand for upstream API continues to rise. Domestic API suppliers are mainly concentrated in East China and South China, and the substitution of imported API has been gradually realized.

The original research enterprise of desloratadine is Schering-Plough (now under Merck & Co., Inc.), and the original research brand name is "Aerius". The core compound patent of desloratadine expired in the United States in 2004, and the compound patent in China expired in 2009. The main dosage form approved for the original research drug is tablet with a specification of 5mg, which has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. Up to now, more than 30 domestic enterprises have obtained A status for their desloratadine API through CDE registration and can officially supply the market. Corresponding multiple dosage forms such as oral preparations and dry suspensions have all been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of desloratadine impurity reference standards. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of various scenarios such as API R&D, quality research and consistency evaluation.