Ketotifen

As a category of chronic diseases with high global incidence, allergic diseases cover the entire age group from children to the elderly, and have long-standing clinical pain points of high recurrence rate and great difficulty in symptom control. Ketotifen is a second-generation antihistamine allergic medium release inhibitor, which can simultaneously antagonize histamine H1 receptors and inhibit the release of allergic mediators from mast cells and basophils. With its dual mechanism of action, its central sedative side effect is significantly lower than that of first-generation antihistamines. It is widely used in the prevention and long-term treatment of a variety of allergic diseases such as bronchial asthma, allergic rhinitis, urticaria and allergic conjunctivitis in clinical practice, and is especially suitable for the pediatric patient group who need long-term control of allergic symptoms.

At present, the global market size of ketotifen preparations exceeds 320 million US dollars, and the annual growth rate of the Chinese market is stable at around 4.8%. As a mature variety that has been on the market for more than 40 years, the ketotifen market is dominated by generic drugs. Domestic API manufacturers are concentrated in East China and South China, and the overall supply pattern is stable. Among them, oral preparations have been included in the National Essential Drug List, and the proportion of demand from primary medical institutions has increased year by year to 42%.

The original research enterprise of ketotifen is Novartis, and the original research trade name is Zaditen. The core compound patent expired globally in 1988. At present, the main dosage forms of the original research that have been marketed include oral tablets (1mg), oral solution (1mg/5ml) and nasal spray. Its oral tablets have been included in the Chinese Reference Listed Drug Catalogue of Chemical Drugs, and are also included in the FDA Reference Listed Drug Catalogue. Up to now, there are more than 20 valid registration numbers of ketotifen APIs on the API registration platform of China CDE, among which 11 have passed the associated review with preparations. The domestically approved and marketed ketotifen preparations cover multiple dosage forms such as tablets, capsules, nasal drops and eye drops. (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 ketotifen API. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in the whole cycle of R&D, quality research and production.