Dicycloverine/Dicyclomine

Paroxysmal abdominal pain caused by gastrointestinal spasm is a common condition in gastroenterology outpatient clinics. Such symptoms are mostly mediated by excessive contraction of smooth muscle and excessive release of acetylcholine, and conventional antispasmodic drugs often have limitations of adverse reactions such as dry mouth and constipation. Dicyclomine belongs to the tertiary amine class of anticholinergic antispasmodic drugs. It can competitively block M receptors on smooth muscle, directly act on gastrointestinal smooth muscle and inhibit its involuntary contraction without affecting the normal secretion of gastric acid. It is mainly used to relieve abdominal pain and spasm symptoms caused by irritable bowel syndrome and functional gastrointestinal diseases, and can be used by adults and children over 6 years old under the guidance of physicians. Due to its weak penetration into the central nervous system, the incidence of adverse reactions such as drowsiness and blurred vision is lower than that of traditional anticholinergic drugs.

At present, the global market size of dicyclomine is approximately USD 230 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the rising prevalence of functional gastrointestinal diseases and the release of demand for antispasmodic drugs in primary healthcare. The Chinese market accounts for 8.7% of the global share. The current competitive landscape is dominated by generic drugs, with the original research product accounting for less than 15% of the market. Three domestic enterprises have obtained approval for generic drug preparations, and there is no record of centralized procurement implementation for this variety. There is still considerable room for domestic substitution in the API supply end.

The original research enterprise of dicyclomine is AbbVie Inc., and the original brand name is Bentyl. The core compound patent in the US market expired in 2009, and the compound patent in China has also expired. The main dosage forms approved for the original product are tablets, with conventional specifications including 10mg and 20mg, which have been included in the FDA Orange Book Reference Listed Drug Catalog. The original product has not yet been included in the domestic Reference Listed Drug Catalog. As of the retrieval time, there is no valid registration number of dicyclomine on the API registration platform of China CDE, and all domestic approved and marketed preparations are domestic generic drugs. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of dicyclomine, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises for impurity qualitative and quantitative research, stability investigation and registration declaration.