Fesoterodine

Overactive bladder (OAB) is a chronic urinary disease with high incidence among middle-aged and elderly groups. Its core inducing factor is the abnormal activation of M3 receptors in the bladder detrusor, which can lead to symptoms such as urgent urination, frequent urination and urgent urinary incontinence, and seriously affects the social interaction and quality of life of patients. Fesoterodine is a highly selective muscarinic M3 receptor antagonist and a new generation of OAB therapeutic drugs. After entering the body, it can be rapidly metabolized into the active product 5-hydroxymethyl tolterodine. By selectively blocking M3 receptors on bladder smooth muscle, it inhibits involuntary contraction of detrusor muscle, and at the same time greatly reduces the affinity for M receptors in other parts such as salivary glands. The incidence of adverse reactions is significantly lower than that of traditional anticholinergic drugs, and it is currently a first-line drug recommended by domestic and foreign OAB diagnosis and treatment guidelines.

The global market size related to fesoterodine was approximately USD 1.27 billion in 2023, with a stable compound annual growth rate of 6.2% from 2019 to 2023. The growth momentum mainly comes from the increase in OAB consultation rate under the intensification of global population aging, and the release of demand for highly tolerated OAB drugs in the primary market. In terms of competitive landscape, the original research product still accounts for more than 60% of the global market share, and the Chinese market is still in the introduction period. At present, 3 domestic enterprises have obtained the production approval for fesoterodine preparations, and the supply gap of active pharmaceutical ingredients (APIs) is relatively large. Since 2024, multiple provinces have included fesoterodine in the Class B medical insurance catalog, and the market demand is expected to enter a rapid growth stage.

The original research enterprise of fesoterodine is Astellas Pharma, and the original research trade name is Enablex. Its core compound patent in the United States expired in 2022, and the compound patent in China expired in 2023. The main dosage form approved by the original research is sustained-release tablets, with specifications of 4mg and 8mg. The 8mg specification has been included in the *Catalogue of Reference Preparations of Chemical Drugs (Second Batch)* of China, and is also listed as a reference preparation by the FDA. Currently in China, the fesoterodine APIs of 6 enterprises have completed registration with the CDE with the status of A, and the marketing applications for generic fesoterodine sustained-release tablets submitted by another 11 enterprises have been approved. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO provides a full set of fesoterodine impurity reference standards, which can meet the needs of the whole process of API R&D, registration and declaration, and quality inspection. Most 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 such as Chinese Pharmacopoeia and FDA, and can be directly used for impurity qualitative and quantitative research and stability investigation, helping enterprises efficiently promote the R&D and declaration of fesoterodine related products.