Loratadine

As a chronic disease with high incidence worldwide, the prevalence of allergic diseases continues to rise. Second-generation antihistamines have become the first-line clinical medication regimen by virtue of their advantages of low drowsiness and long duration of action. Loratadine is a second-generation tricyclic antihistamine. It can selectively antagonize peripheral H1 receptors and inhibit the release of allergic mediators such as histamine, so as to effectively relieve the symptoms and signs of sneezing, runny nose, nasal itching, nasal congestion caused by allergic rhinitis, as well as other allergic skin diseases such as chronic urticaria and pruritic skin diseases. The applicable population covers adults and children over 2 years old, so it has a wide range of clinical application scenarios.

At present, the global market size of antihistamines exceeds 8 billion US dollars. As a mature variety, loratadine has a stable global annual sales volume of about 1.2 billion US dollars, and its annual sales volume in the Chinese market is nearly 2 billion yuan. The overall market size maintains a low and steady growth rate of 3%. In terms of the competitive landscape, the patent of this drug has long expired. At present, there are more than 130 domestic preparation approvals, and more than 30 enterprises have been approved for API, making it a mature variety with sufficient competition. After centralized procurement, the terminal price has dropped significantly, and the clinical accessibility has been greatly improved. The upstream API supply is basically dominated by local enterprises, and the proportion of imported API is less than 5%.

The original research enterprise of loratadine is Bayer (formerly Schering-Plough), and the original research brand name is Claritin®. Its core compound patent expired globally in 2004, and the compound patent in China also expired in 2004. The main marketed dosage forms of the original research include tablets, capsules and syrups, among which the specification of immediate-release tablets is 10mg, and the specification of syrup is 60ml:60mg. The original 10mg tablet has been included in the Chinese *Catalogue of Reference Preparations of Chemical Drugs*, and is also a reference preparation designated by the FDA. At present, the Chinese API registration platform shows that there are more than 20 loratadine API registration numbers, among which more than 15 are in status A. The domestically approved loratadine preparation products cover tablets, capsules, granules, syrups and other dosage forms. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for loratadine API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, they meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements of the whole process of drug research and development, quality research, production quality control, etc., so as to provide stable and reliable support for the product research and development and quality control of relevant enterprises.