Tiotropium

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high disability rate, and there has been an urgent clinical demand for long-acting bronchodilators for a long time. Tiotropium bromide is a long-acting muscarinic antagonist (LAMA). It exerts a long-lasting bronchodilatory effect by specifically blocking the M3 receptors on airway smooth muscle, and the efficacy of a single administration can last for 24 hours. It is a first-line drug for maintenance treatment of stable COPD, and can also be used to relieve airway spasm symptoms in asthma patients. Its applicable population covers adult patients with moderate to severe chronic airway diseases, and it can significantly reduce the frequency of acute exacerbations, improve lung function and quality of life.

At present, the global tiotropium bromide market size is stable at around USD 5 billion, and the annual sales in the Chinese market exceed RMB 2.5 billion. With the improvement of the early screening rate for COPD patients and the accessibility of primary care medication, the compound annual growth rate in the past three years has remained at 6.8%. In terms of the competitive landscape, the original research product still accounts for nearly 60% of the market share. More than 10 domestic enterprises have obtained generic preparation products that have passed the consistency evaluation. After the centralized procurement, the price of preparations has dropped by more than 80%, driving the continuous rise in demand for upstream APIs. The proportion of domestic API supply has increased from 23% in 2019 to 61% in 2023.

The original research enterprise of tiotropium bromide is Boehringer Ingelheim, and the original trade name is Spiriva®. Its core compound patent expired in the United States in 2018, and the core patent in China also expired in 2018. The main dosage forms of the original research product on the market include inhalation powder (18μg) and inhalation spray (2.5μg/puff). Both dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also included in the FDA reference preparation catalogue. In terms of domestic API registration, 12 enterprises including Boehringer Ingelheim have obtained CDE registration numbers for tiotropium bromide APIs, among which 9 are in status A (approved for use in marketed preparations). More than 20 tiotropium bromide preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for tiotropium bromide API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research and registration declaration.