Ebastine

As a chronic disease with high incidence worldwide, allergic diseases have long required antihistamines with both long-term efficacy and tolerability for clinical treatment. Ebastine is a second-generation H1 antihistamine that can selectively block peripheral H1 receptors and inhibit the release of inflammatory mediators such as histamine from mast cells. It has no obvious central sedative effect and will not have a significant impact on patients' daily work and cognitive function. It is mainly used clinically to treat allergic rhinitis (including seasonal and perennial), chronic idiopathic urticaria, allergic conjunctivitis and other diseases, covering adults and children over 2 years old. It is a commonly used first-line drug in the stepwise treatment of allergic diseases.

The global market size of ebastine preparations has maintained steady growth in recent years. In 2023, the overall market size exceeded 1.2 billion US dollars, of which the Chinese market accounted for about 18%, and the compound annual growth rate remained at around 6%. As the core patents have long expired, the domestic generic drug market is fully competitive. At present, more than 20 enterprises have obtained the production approval of ebastine preparations. After the implementation of volume-based procurement, the price of preparations has dropped by more than 60%. The supply stability and cost control of upstream API have become the core competitive factors for downstream preparation enterprises. Domestic API manufacturers are mainly concentrated in Jiangsu, Zhejiang and other regions.

The original research enterprise of ebastine is Almirall S.A. (Spain), and the original research trade name is "Kestine". Its core compound patent was first applied for in 1983. The patents in major markets such as Europe and the United States expired around 2004, and the compound patent in China also expired in 2005. The dosage form approved by the original research in China is tablet, with specifications of 10mg and 20mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 13 ebastine registration records on the CDE API registration platform, 8 of which have been activated and publicized and can be associated with preparation declaration. More than 15 domestic enterprises have obtained approval for the marketing of ebastine tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of ebastine impurity reference standards. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They comply with multiple regulations including Chinese Pharmacopoeia and FDA, which can fully meet the full-process needs of API R&D, quality research and compliance declaration, and help enterprises shorten the R&D cycle and reduce quality control costs.