Otilonium Bromide

Irritable bowel syndrome, as a common functional gastrointestinal disease, has a global prevalence as high as 10%~20%. Patients often suffer from recurrent symptoms such as abdominal pain, abdominal distension and changes in bowel habits, and there has been a long-term lack of clinical treatment options with both targeting properties and safety. Otilonium bromide is an antispasmodic and anticholinergic drug, which can specifically act on the gastrointestinal smooth muscle, exert an antispasmodic effect by inhibiting calcium influx and blocking muscarinic receptors, and is not easy to pass through the blood-brain barrier, with a very low risk of central adverse reactions. This drug is indicated for the symptomatic treatment of diseases related to gastrointestinal smooth muscle spasm such as irritable bowel syndrome, gastritis, gastroduodenitis, enteritis and esophageal lesions, and can also be used for preoperative preparation before endoscopic examinations (such as gastroscopy, colonoscopy, proctoscopy). The applicable population covers adults and middle-aged and elderly patients requiring gastrointestinal antispasmodic intervention.

At present, the global market size of otilonium bromide is approximately USD 320 million, and the compound annual growth rate from 2021 to 2026 is expected to be 4.8%. The growth momentum mainly comes from the increased consultation rate of functional gastrointestinal diseases and the popularization of gastrointestinal endoscopy. The Chinese market accounts for approximately 12% of the global share, and the current competitive landscape is dominated by the original research product. Three domestic enterprises have been approved for generic drug preparations. In the 2022 provincial-level centralized procurement, the winning bid price of otilonium bromide tablets was reduced by up to 69% compared with the original research product. With the increase in the penetration rate of generic drugs, the market accessibility is continuously improving.

The original research enterprise of otilonium bromide is the German Menarini Group, and the original research trade name is Spasmomen. Its core compound patent expired in 2009 in major markets such as the European Union and the United States, and the Chinese compound patent expired in the same period. The main dosage form of the original research product is tablet, with a specification of 40mg, which has been included in the *Catalogue of Chemical Reference Preparations (29th Batch)* of China, and is also listed as an FDA reference preparation. As of now, there are 4 registration entries of otilonium bromide API on the Chinese CDE API Registration Platform, of which 2 are in A status and can be marketed and used in China. 6 generic varieties of otilonium bromide tablets have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for otilonium bromide, covering the full spectrum of process impurities and degradation impurities. Most products are directly available in stock, and stock orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of API enterprises in all stages of R&D, registration and quality control.