Fluralaner

Infections caused by ectoparasites such as ticks and fleas have long plagued the health of companion animals, and the problem of drug resistance has further posed challenges to clinical prevention and treatment. The advent of fluralaner has provided a brand-new solution for the field of veterinary anthelmintics. As a new isoxazoline class of anti-parasite active pharmaceutical ingredient, fluralaner selectively blocks the glutamate-gated chloride channels and γ-aminobutyric acid-gated chloride channels of parasites, leading to overexcitation of the parasite nervous system, paralysis and death. It has extremely low affinity for mammalian ion channels, and thus has outstanding safety. At present, it is mainly used for the prevention and treatment of ectoparasite infections in dogs and cats, and can kill fleas and multiple tick species at the same time. Some compound preparations can also prevent and control endoparasites simultaneously, making it one of the core ingredients in the global companion animal anthelmintic market.

The global market size of veterinary anthelmintics has exceeded 10 billion US dollars, among which isoxazoline products account for nearly 30% of the market share by virtue of their broad-spectrum and high-efficiency advantages. As a representative variety of this category, fluralaner has maintained a compound annual growth rate of more than 12% in the past five years. At present, the market supply is dominated by original research enterprises. As core patents expire one after another, generic drug enterprises are accelerating their layout. China is the main potential supplier of fluralaner API in the world, and a number of enterprises have started registration and declaration work.

The original research enterprise of fluralaner is Boehringer Ingelheim, and the original research trade name is NexGard. The expiration time of its core compound patent in China is 2029. The main dosage forms approved by the original research are oral chewable tablets, with common specifications including 11.3mg, 28.3mg, 68mg, 136mg and 272mg, which have been included in the FDA Reference Listed Drug Catalog for animal drugs. Up to now, there is no approved fluralaner preparation product on the market in China, and no fluralaner registration number with A status has been found on the CDE API registration platform for the time being. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of fluralaner impurity reference standards, most of which are in stock. For in-stock products, orders placed 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 various reference standard needs of enterprises in the stages of API R&D, quality research and registration declaration.