Trospium

Overactive bladder (OAB), a highly prevalent urogenital disease, is often accompanied by symptoms such as urgent urination, frequent urination, and urge incontinence, which severely affect patients' quality of life. Trospium chloride is a quaternary ammonium antimuscarinic drug. It can competitively block M receptors on bladder smooth muscle, inhibit involuntary contraction of the detrusor muscle, and reduce bladder excitability. Due to its molecular properties, it is not easy to penetrate the blood-brain barrier, resulting in a low risk of central adverse reactions. It is suitable for symptom control in adult patients with overactive bladder, especially for the elderly patient group with high requirements for central tolerance.

At present, the global market size related to trospium chloride is approximately USD 320 million, with a compound annual growth rate of around 4.7% from 2023 to 2028. The growth is mainly driven by the popularization of urological disease screening and the release of demand from the primary market. The sales revenue of trospium chloride preparations at the terminal of Chinese public medical institutions exceeded RMB 120 million in 2023, with a year-on-year growth of 8.2%. The current market is dominated by original research products, and 3 domestic enterprises have obtained approval for generic preparations. With the expansion of the coverage of centralized drug procurement, there is still considerable room for improvement in market penetration.

The original research enterprise of trospium chloride is Astellas Pharma Inc. of Japan, with the original brand name "Uritract". Its core compound patents in major markets such as Europe and the United States expired in 2019, and the compound patent in China also expired in 2019. The main dosage form of the original product is tablet, with a conventional specification of 20 mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, there have been 8 registration records of trospium chloride API on the API Registration Platform of China Center for Drug Evaluation (CDE), among which 6 have been activated (Status A), and generic trospium chloride tablets have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

In response to the R&D and quality control requirements for trospium chloride, CATO provides a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support pharmaceutical enterprises in process research, quality standard establishment and declaration work.