Dimetindene

Allergic diseases are a group of chronic diseases with high global incidence, and antihistamines are the core drug category for symptomatic treatment. Dimetindene belongs to the first-generation alkylamine antihistamines. It inhibits histamine-mediated allergic reactions such as vasodilation and smooth muscle contraction by competitively blocking H1 receptors, and also has certain anticholinergic and sedative effects. Clinically, it can be used for symptomatic relief of various allergic diseases such as urticaria, allergic rhinitis, eczema, and pruritus, and can also assist in relieving runny nose and nasal congestion caused by common cold, with the applicable population covering adults and children over 6 years old.

The current global market size of antihistamines exceeds USD 12 billion. Among them, first-generation antihistamines still maintain stable demand in primary medical care and OTC scenarios due to their cost-effectiveness advantage. As a细分 variety, dimetindene has its main markets concentrated in Europe, Southeast Asia and some South American countries, with a stable global annual sales volume in the range of USD 120 million to 150 million. The domestic market is still in the introduction stage at present, with only a small amount of imported preparations in circulation and no domestic generic drugs launched yet, leaving a highly blank competitive landscape. With the continuous rise in the prevalence of allergic diseases in China, the clinical supplementary value of this variety is gradually attracting the attention of domestic pharmaceutical companies.

The original developer of dimetindene is Boehringer Ingelheim of Germany, with the original brand name Fenistil. The core compound patent expired globally around 1980. The mainstream dosage forms of the original product include 1mg tablets, 0.1% oral solution and 0.1% topical gel. Among them, the tablets and topical gel have been included in the FDA Reference Listed Drug Catalog, while China NMPA has not yet included the reference listed drug of this variety. Up to now, there is no valid registration number (status A or status I) of dimetindene on the CDE API registration platform. Only a few import registration certificates for the original topical gel have been approved in China, and no domestically produced dimetindene preparations have been approved for marketing. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the R&D and production quality control needs of dimetindene, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support pharmaceutical companies in impurity research, quality standard establishment and declaration-related work.