Triprolidine

Allergic diseases fall into the category of chronic diseases with high clinical incidence, and the patient population covers all age groups. The impact of symptoms such as pruritus and mucosal edema during their onset on quality of life has long received clinical attention. Triprolidine is a first-generation propylamine H1 antihistamine. It competitively blocks histamine H1 receptors to inhibit the histamine-mediated allergic reaction pathway, and meanwhile has weak anticholinergic and sedative effects. Clinically, it is mainly used for the treatment of common allergic diseases such as allergic rhinitis, urticaria, allergic conjunctivitis, and pruritus cutanea. Its applicable population covers adults and children over 2 years old, and it is one of the commonly used drugs for symptomatic treatment of allergies at the primary care level.

At present, the overall global market size of antihistamines has exceeded 12 billion US dollars. Among them, first-generation antihistamines still occupy a stable market share in primary care and OTC retail channels due to their cost-performance advantage. As a variety with relatively controllable adverse reactions in this category, the annual global market demand for triprolidine is about 180 tons. In terms of the domestic market, triprolidine-related preparations have been included in the list of commonly used drugs for primary medical institutions in some provinces, with annual sales maintaining a steady growth rate of 4%-6%. The competitive landscape is dominated by generic drugs, and the supply of APIs is currently dominated by domestic pharmaceutical manufacturers, with imported registered products accounting for less than 15%.

The original research enterprise of triprolidine is GlaxoSmithKline, and the original brand name is "Actidil". The core compound patent of triprolidine expired worldwide in 1979. The main dosage forms approved for the original research product are oral tablets and capsules, both with a specification of 2.5 mg, and the original research preparation has been included in the FDA Reference Listed Drug Catalog. For the domestic market, there are currently 4 triprolidine API registration numbers on the CDE API registration platform, 2 of which are in Status A and can be used for association with domestic preparation applications. The domestically approved triprolidine preparations that have been launched include triprolidine hydrochloride tablets and triprolidine hydrochloride capsules, both of which are generic varieties. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for triprolidine API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of API enterprises in the whole process of quality research, impurity control, registration and declaration, etc.