Alcaftadine

Allergic conjunctivitis is a highly prevalent ocular surface allergic disease worldwide. Patients are often repeatedly troubled by symptoms such as ocular itching, conjunctival hyperemia and lacrimation. Antihistamines and mast cell stabilizers conventionally used in clinical practice have the shortcomings of single mechanism of action and slow onset of effect. Alcaftadine is a third-generation antihistamine that also has a potent mast cell stabilizing effect. It exerts its effect through the dual mechanisms of blocking histamine H1 receptors and inhibiting the release of inflammatory mediators from mast cells. It can rapidly relieve allergic symptoms with long-lasting effect, and is mainly used for the prevention and treatment of allergic conjunctivitis. It is suitable for patients of all age groups including children aged 2 years and older and adults, and is currently a first-line drug in the field of ophthalmic allergy.

The global market size of alcaftadine preparations is nearly US$300 million. Driven by the逐年上升的患病率 of allergic diseases, the annual compound growth rate of the market remains at around 4.2%. The Chinese market is currently in a stage of rapid growth. In 2023, alcaftadine accounted for approximately 6.8% of the domestic ophthalmic allergy medication market, with a growth rate exceeding 12%. In terms of competitive landscape, the original research product still occupies the major market share. Only a small number of domestic enterprises have obtained approval for generic drugs, and the supply of API has not yet formed sufficient competition, with a clear market gap.

The original research enterprise of alcaftadine is Santen Pharmaceutical of Japan, and the original trade name is Patanol? No, that’s incorrect. Oh, no, Patanol is olopatadine. Oh right, is the original research of alcaftadine Alcon? No, check again: Oh, the original research of alcaftadine is Alcon Laboratories, Inc. of the United States, with the trade name Lastacaft, which was approved for marketing by the FDA in 2010. The compound patent in China expired in 2023. The original dosage form is eye drops, with a specification of 0.25% (1.5ml:3.75mg). The original eye drops have been included in the FDA Reference Listed Drug Catalogue, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (Fifth Batch)* of China. In terms of domestic API registration, as of now, there are only 3 registration records of alcaftadine API on the CDE API registration platform, among which 1 is in status A and 2 are in status I; 2 domestic enterprises have obtained approval for marketing of alcaftadine 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 alcaftadine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API R&D, quality research and generic drug consistency evaluation.