Darifenacin

Overactive bladder (OAB) is a common urinary system disease affecting more than 400 million people worldwide, with urgent urination, frequent urination and urge urinary incontinence as core symptoms, which severely reduces the quality of life of patients. Darifenacin is a highly selective M3 muscarinic receptor antagonist. It inhibits involuntary bladder contraction by specifically blocking M3 receptors on bladder smooth muscle, and meanwhile reduces the affinity for M1 and M2 receptors in salivary glands, heart and other parts, greatly reducing the adverse reactions of traditional anticholinergic drugs such as dry mouth and palpitations. It is a first-line drug for long-term treatment of overactive bladder in adults, and is especially suitable for middle-aged and elderly patients with poor tolerance to non-selective anticholinergic drugs.

The global market size related to darifenacin was approximately USD 420 million in 2023, with a compound annual growth rate of 3.8% from 2019 to 2023. The growth drivers mainly come from the increase in the consultation rate of OAB and the rise in the prevalence rate among the elderly. In terms of the competitive landscape, the market share of generic drugs has exceeded 65% after the patent expiration. China and India are the main suppliers of generic drug APIs. Driven by the domestic centralized procurement policy, the price of related preparations has dropped by 78%, which further drives the demand growth of upstream APIs.

The original research enterprise of darifenacin is Novartis, and the original trade name is Enablex. The core compound patent expired in 2018 in the United States, and in 2015 in China. The main dosage form approved for the original drug is sustained-release tablets, with specifications of 7.5mg and 15mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. According to the data of the domestic API registration platform, the darifenacin APIs submitted by 3 enterprises have passed the CDE registration with the status of A, and the registration applications of another 8 enterprises are under review. A number of domestic enterprises have obtained approval for the marketing of darifenacin sustained-release tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for darifenacin API, covering the whole chain including synthetic starting materials, intermediates and degradation impurities. Most products are regularly available in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of pharmaceutical enterprises in R&D, quality research and consistency evaluation.