Dyclonine

As a classic and commonly used drug in the field of local anesthesia, dyclonine belongs to the amide class of local anesthetics. It blocks the sodium channels on the nerve cell membrane and inhibits the generation and conduction of nerve impulses, thereby exerting rapid and long-lasting local anesthesia, analgesic and antipruritic effects. It is mainly used clinically for surface anesthesia of skin and mucous membranes. Common indications include pre-operative anesthesia for oropharyngeal surgery, local lubrication anesthesia for endoscopic examinations such as gastroscopy and laryngoscopy, and can also be used for skin itching and pain relief caused by allergic dermatitis, insect bite dermatitis, etc. The applicable population covers patients of all age groups requiring local procedures, and it can be used safely when there are no clear contraindications.

At present, the global market size of dyclonine preparations is approximately USD 180 million, and the annual growth rate of the Chinese market is maintained at around 7%. The demand is mainly concentrated in the endoscopy centers, stomatology departments and dermatology departments of medical institutions. Due to its early launch time, there is no core patent restriction on this drug, and the participation of domestic generic pharmaceutical enterprises is relatively high. More than 10 enterprises have been approved to produce dyclonine-related preparations, among which topical creams, topical solutions and mucilages are the mainstream dosage forms. After the implementation of the centralized procurement policy, the price of the selected preparations has dropped by 62%, further promoting the steady increase in clinical usage.

The original research enterprise of dyclonine is Johnson & Johnson of the United States, with the original trade name "Sarana". Its core compound patent expired globally in 1970, and there is no valid core patent restriction at present. The mainstream dosage forms of the original product include 1% topical cream, 0.5% topical solution and 10mg/ml mucilage. Among them, the 0.5% dyclonine topical solution has been included in the FDA Reference Listed Drug Catalog, while the original product has not been included in the domestic Reference Listed Drug Catalog for the time being. As of now, 3 enterprises in China have obtained CDE registration numbers (status A) for dyclonine APIs, and a total of 6 dosage forms of preparation products including dyclonine hydrochloride mucilage and dyclonine hydrochloride cream have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for dyclonine API, and supports custom synthesis routes and structure confirmation services. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most of the impurity reference standards are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can efficiently meet various needs of pharmaceutical enterprises in R&D and quality control links.