Imidafenacin

Overactive bladder (OAB) is a common chronic disease of the urinary system, and its global prevalence continues to rise with the aging of the population. Symptoms such as frequent urination, urgent urination and urge urinary incontinence in patients seriously affect their quality of life. Imidafenacin is a third-generation highly selective M3 receptor antagonist. It can inhibit the excessive contraction of detrusor muscle by blocking the M3 receptor on bladder smooth muscle, and at the same time reduce the affinity to M1 and M2 receptors related to the central nervous and cardiovascular systems, greatly reducing adverse reactions such as dry mouth, constipation and cognitive impairment. This drug is mainly used for the symptomatic treatment of overactive bladder in adults, especially suitable for elderly patients and OAB population with underlying diseases, and its clinical tolerance is better than that of previous generations of anticholinergic drugs.

The current global market size of imidafenacin is approximately US$210 million, with a compound annual growth rate maintained at 4.7%. The growth momentum mainly comes from the increase in the OAB consultation rate of the elderly population and the improvement of drug accessibility in emerging markets. In terms of the domestic market, with the advancement of the volume-based procurement policy, the terminal price of imidafenacin preparations has dropped by more than 70%. In 2023, the domestic market size exceeded RMB 120 million, and the market share of generic drugs has reached 89%. At present, there are less than 5 enterprises in China with the production qualification of this API, and there is still a supply gap.

The original research enterprise of imidafenacin is Ono Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "Uritos". Its core compound patent expired in Japan in 2021, and the Chinese compound patent expired in 2022. The main dosage form of the original research product is oral tablet, with specifications of 0.1mg and 0.2mg. The original research tablet has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Orange Book. At present, the imidafenacin APIs of 3 domestic enterprises have obtained A status through CDE registration, and a total of 6 domestic enterprises have obtained approval for the marketing of imidafenacin tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for imidafenacin, most of which 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 compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation.