Olopatadine

Allergic diseases, as highly prevalent chronic diseases worldwide, continuously trouble more than 20% of the population, and antihistamines are the core option for clinical control of allergic symptoms. Olopatadine is a second-generation highly selective H1 receptor antagonist, which also has mast cell membrane stabilizing effect and can doubly block the occurrence pathway of allergic reactions. Compared with first-generation antihistamines, it has a lower risk of central nervous system inhibition, and the incidence of adverse reactions such as drowsiness and fatigue is significantly reduced. At present, its clinical indications cover common allergic diseases such as allergic rhinitis, urticaria, pruritus cutanea, and allergic conjunctivitis, and the applicable population covers adults and children over 3 years old. It is a mainstream drug in the field of allergy that balances safety and effectiveness.

In recent years, the global olopatadine market size has maintained a steady growth trend. In 2023, the overall market size was approximately USD 1.48 billion, with a compound annual growth rate of around 5.2%. Driven by factors such as the rising prevalence of allergic diseases and the expanding demand for pediatric allergy diagnosis and treatment, the growth rate of the domestic market is higher than the global average. In 2023, the total sales of domestic public hospitals and retail terminals were approximately RMB 1.27 billion, with a compound annual growth rate of 7.8%. At present, the original research products still account for about 60% of the domestic market share. With the expiration of core patents, olopatadine preparations from more than 15 local enterprises have been approved for marketing. After the implementation of centralized procurement, the price of generic drugs has dropped by more than 70%, and accessibility has been greatly improved.

The original research enterprise of olopatadine is Kyowa Hakko Kirin Co., Ltd. of Japan, and the original trade name is "Allelock". Its core compound patent in Japan expired in 2010, the indication patent in China expired in 2017, and the preparation patent in the United States expired in 2020. At present, the main dosage forms of the original research product approved globally include oral tablets, oral solutions and eye drops. The original research dosage forms already marketed in China are 5mg tablets and 0.1% eye drops. The original research product of this variety has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and has also been included as a reference preparation by the FDA. Up to now, more than 30 domestic enterprises have obtained A status for their olopatadine API through CDE registration, which can be directly associated with preparation declaration. The preparations approved for marketing in China cover multiple dosage forms such as tablets, eye drops and nasal sprays. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of olopatadine impurity reference standards. Most products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of different stages such as API R&D, quality research, and registration declaration.