Propiverine

Overactive bladder (OAB) is a common chronic urinary system disease with a global prevalence of over 10%. While it significantly reduces the quality of life of patients, it also drives the demand for highly tolerable therapeutic drugs. Propiverine is a mixed muscarinic receptor antagonist with additional calcium antagonistic effect. It exerts its effect through the dual mechanisms of inhibiting involuntary detrusor contraction and reducing intravesical pressure. Meanwhile, it has low affinity for the central nervous system, resulting in lower risk of cognitive side effects. Clinically, it is mainly used to improve the symptoms of frequent urination, urgent urination and urge urinary incontinence caused by OAB, and is especially suitable for long-term use in middle-aged and elderly patients and OAB populations with underlying diseases.

At present, the global market size related to propiverine exceeds 400 million US dollars, with a compound annual growth rate of approximately 5.8%. The growth momentum mainly comes from the improvement of the diagnosis and treatment penetration rate of OAB in primary care and patients' demand for drugs with low side effects. The domestic market is currently dominated by generic drug supplies, which have been included in the local centralized procurement catalogs of multiple provinces. The winning bid price has dropped by about 62% compared with the original research drug, and the accessibility in primary care has been greatly improved. However, there is still a certain gap in the supply of compliant active pharmaceutical ingredients and supporting impurity reference substances, which is the core layout direction for supply chain enterprises.

The original research enterprise of propiverine is Japan's Kyorin Pharmaceutical Co., Ltd., with the original brand name "Flipad". The core compound patent of propiverine expired in Japan in 2007, and the compound patent in China expired in 2008. The main dosage form approved for the original research drug is tablet, with specifications of 10mg and 20mg. The original research tablets have been included in the China Listed Drug Catalog as reference preparations. Up to now, there are 6 pieces of propiverine API registration information on the CDE API Registration Platform, among which 3 have been activated with A status. A total of 10 domestic enterprises have obtained marketing approval for propiverine tablets and sustained-release tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for propiverine API, covering the full spectrum of process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can be directly used to support API registration and declaration as well as quality research processes, providing stable support for enterprises to shorten R&D cycles and reduce compliance risks.