Tolterodine

In response to the distress such as urgent urination, frequent urination and urge urinary incontinence caused by overactive bladder (OAB), highly selective M receptor antagonists provide patients with a mild and long-term symptom control regimen. Tolterodine is a classic drug in this therapeutic field. It selectively blocks the muscarinic receptors on the bladder smooth muscle to inhibit involuntary bladder contraction, and meanwhile reduces the affinity for peripheral tissues such as salivary glands. Compared with traditional anticholinergic drugs, the incidence of adverse reactions such as dry mouth and constipation is significantly reduced. It is suitable for long-term maintenance treatment of adult OAB patients, especially for people who have poor response to non-pharmacological interventions.

At present, the global market size of tolterodine-related preparations is approximately USD 1.2 billion, the annual growth rate of the Chinese market remains at around 6%, and the proportion of demand from primary medical institutions has increased year by year to 35%. As the core patent has expired for many years, the domestic generic drug market is highly competitive. Currently, there are more than 80 approved oral preparation approval numbers. After the centralized procurement, the bid-winning price has dropped by up to 92% compared with that of the original research drug, which greatly reduces the medication burden of patients. The API supply side has basically achieved localization, and the production capacity of domestic enterprises accounts for more than 70% of the total global supply.

The original research enterprise of tolterodine is Pfizer, and the original research trade name is "Detrol". Its core compound patent expired in major markets such as the United States and Europe in 2012, and the Chinese compound patent expired in the same period. The main dosage forms approved for the original research drug include conventional tablets (2mg) and sustained-release capsules (4mg), both of which have been included in the Catalogue of Marketed Drugs in China, and are also included in the FDA Reference Listed Drug Catalog. Up to now, 12 registration information of tolterodine API has been publicized on the API registration platform of China CDE, among which 8 are in status A and can be used in association with domestic preparation declarations. The domestic approved tolterodine preparations cover three categories: conventional tablets, sustained-release tablets and sustained-release capsules. (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 tolterodine API, which fully cover impurities generated in the synthesis process, degradation impurities and enantiomers. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All impurities comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support various scenario requirements such as API registration and declaration, quality research, and daily release testing.