Aclidinium bromide

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high disability rate, and there has long been an urgent clinical demand for long-acting bronchodilators with low side effects. Aclidinium bromide is a long-acting muscarinic antagonist (LAMA). By competitively blocking the M3 cholinergic receptors on airway smooth muscle, it inhibits acetylcholine-induced bronchoconstriction and continuously dilates the airways, with a pharmacological effect lasting more than 12 hours. It is mainly used for long-term maintenance treatment of COPD patients, can significantly improve patients' lung function and reduce the risk of acute exacerbations, and is suitable for adult patients with moderate to severe COPD.

At present, the global number of people suffering from COPD has exceeded 300 million, driving the continuous expansion of the long-acting muscarinic antagonist market. As a commonly used LAMA drug in clinical practice, aclidinium bromide had a global market size of approximately USD 420 million in 2023, with a compound annual growth rate maintained at around 5%. The domestic market is still dominated by original research products at present. With the advancement of medical security policies for respiratory disease drugs in recent years and the inclusion of COPD in the chronic disease long-term medication management catalog, the clinical utilization rate of aclidinium bromide has been steadily increasing, and the enthusiasm for generic drug R&D and application has also continued to rise. So far, more than 8 domestic enterprises have submitted marketing applications for generic drugs, and the future import substitution space is considerable.

The original research enterprise of aclidinium bromide is AstraZeneca Pharmaceuticals UK, with the original brand name "Spiriva Respimat". The core compound patent of aclidinium bromide expired in 2021 in the United States and in 2020 in China. The main dosage form approved for the original research product is dry powder inhaler, with a specification of 12 μg per actuation and 60 actuations per box. This original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the reference preparation catalogue of FDA. At present, there are 5 registration entries of aclidinium bromide API on the domestic CDE API registration platform, among which 3 have obtained A status through the associated evaluation with preparations. The original preparation and a number of domestic generic drugs have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for aclidinium bromide API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use requirements in various stages of API R&D, quality research and registration application.