Solifenacin

Overactive bladder (OAB), a common chronic urinary system disease in clinical practice, has urgency, frequent urination and urge urinary incontinence as its core symptoms. The global prevalence rate of OAB exceeds 10%, which severely reduces the quality of life of patients. Solifenacin is a highly selective M3 receptor antagonist, which can competitively block the M3 receptors on bladder detrusor muscle and inhibit excessive bladder contraction, while reducing the effect on M receptors in other parts such as salivary glands. Compared with traditional anticholinergic drugs, the incidence rates of adverse reactions such as dry mouth and constipation of solifenacin are significantly lower. It is currently the first-line therapeutic drug for OAB, suitable for symptom control in adult patients, and can also be used for symptomatic treatment of neurogenic bladder related to spinal cord injury.

At present, the global market size of solifenacin is about USD 1.8 billion, among which emerging markets maintain a compound annual growth rate of 6.2%. The sales of solifenacin at the terminal of Chinese public medical institutions have been stable at around RMB 1.2 billion in recent years. With the advancement of hierarchical diagnosis and treatment and the improvement of patients' disease awareness, the primary market has sufficient expansion space. In terms of competitive landscape, the original research product still accounts for nearly 60% of the market share. 5 domestic enterprises have been approved for generic drugs, and this variety has been included in the 7th batch of centralized national drug procurement. The winning bid price has dropped by about 71% compared with that before the centralized procurement, and the generic drug substitution process continues to accelerate.

The original research enterprise of solifenacin is Astellas Pharma, and the original trade name is "Vesicare". Its core compound patent expired in the United States in 2018, and the Chinese compound patent also expired in 2018. The marketed dosage form of the original research product is oral tablet, with specifications of 5mg and 10mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, 7 enterprises including Qilu Pharmaceutical and Sichuan Kelun have obtained CDE registration numbers for solifenacin APIs, among which 6 registration statuses are "A" (can be used in marketed drugs). A number of domestic manufacturers have been approved for marketing of solifenacin tablets, and more than 10 product specifications of generic preparations have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for solifenacin API, covering all types such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. The products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the various needs of pharmaceutical enterprises for quality research, stability study and registration declaration.