Ipratropium

One of the core pathological features of chronic airway diseases such as chronic obstructive pulmonary disease (COPD) and bronchial asthma is airway smooth muscle spasm and excessive secretion of secretions, and clinical practice has long relied on drugs with both bronchodilator and anticholinergic activities to achieve symptom control. Ipratropium bromide is a short-acting anticholinergic bronchodilator. It competitively blocks M3 cholinergic receptors on airway smooth muscle, inhibits vagus nerve-mediated smooth muscle contraction, and reduces the secretion of airway mucous glands, with the advantages of fast onset and few adverse reactions. At present, its single-agent products and compound preparations combined with β2 receptor agonists have been recommended by domestic and foreign guidelines as basic medications for the stable phase of COPD, and can also be used to relieve airway spasm symptoms in acute asthma attacks, covering applicable populations of all age groups including adults and children.

The global market size of ipratropium bromide-related preparations has maintained steady growth in recent years. The overall market size was approximately USD 1.28 billion in 2023, and is expected to increase to USD 1.63 billion by 2028, with a compound annual growth rate of approximately 4.9%. Driven by the rising prevalence of COPD and the popularization of primary-level medication in the domestic market, the terminal sales of public medical institutions were approximately RMB 1.86 billion in 2023, among which the inhalation solution dosage form accounts for more than 85%. In terms of the competitive landscape, the original research product still accounts for about 35% of the market share. More than 15 domestic enterprises have obtained approval for generic preparations, which have been included in the seventh batch of national centralized drug procurement. The winning bid price is about 78% lower than that of the original research product, further promoting the improvement of clinical accessibility.

The original research enterprise of ipratropium bromide is Boehringer Ingelheim, and the original research trade name is "Atrovent". Its core compound patent expired in 1999 in major markets around the world. At present, the dosage forms of the original research product approved in China include inhalation solution and aerosol. The specifications of the inhalation solution are 2ml:500μg and 2ml:250μg, and the specification of the aerosol is 14g:8.4mg (20μg per puff). All relevant dosage forms of the original research product have been included in the Catalogue of Marketed Drugs in China as reference preparations, and are also included in the FDA Reference Preparations List. In terms of domestic API registration, as of now, more than 30 enterprises have obtained Class A status for their ipratropium bromide APIs through CDE registration. For corresponding preparations, ipratropium bromide solution for inhalation from 22 enterprises and ipratropium bromide aerosol from 11 enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ipratropium bromide API, covering reference standards required for the whole research path including synthetic by-products and degradation impurities. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmaceutical regulatory regulations of various countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production quality control needs of pharmaceutical enterprises in the whole process of generic drug consistency evaluation, quality research, stability study, etc.