Olodaterol

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with high disability and mortality rates, and there is a persistent and urgent demand for long-acting bronchodilators in its long-term clinical management. Olodaterol belongs to the class of long-acting β2-adrenoceptor agonists (LABA). By highly selectively activating β2 receptors on airway smooth muscles, it can produce a bronchodilatory effect lasting for more than 12 hours, effectively relieve the symptoms of airflow limitation in COPD patients, and reduce the risk of acute exacerbations. Currently, it is only recommended for the long-term maintenance treatment of adult COPD patients and is not suitable for relieving acute asthma attacks.

The global number of COPD patients has exceeded 300 million, driving the continuous expansion of the olodaterol-related market. In 2023, the global market size of olodaterol and olodaterol-containing compound preparations was approximately USD 1.28 billion, with a compound annual growth rate of 4.2% in the past three years. In terms of the domestic market, with the improvement of the level of medication security in the respiratory field, after olodaterol was included in the National Medical Insurance Catalogue, its terminal volume has increased significantly. In 2023, the domestic market size exceeded RMB 210 million. Currently, the market is still dominated by the original research product, and a number of local pharmaceutical companies have submitted marketing applications for generic drugs. In the future, with the launch of generic drugs, the accessibility of the product will be further improved.

The original research enterprise of olodaterol is Boehringer Ingelheim, and the original trade name is Spiriva Respimat. Its core compound patent expired in Europe in 2024, will expire in the United States in 2025, and has expired in China in 2023. The approved dosage form of the original research product is inhalation spray, with a specification of 2.5 μg olodaterol per actuation, and it has been included in the Chinese Reference Preparation Catalogue and the FDA Reference Preparation Catalogue. At present, more than 10 domestic enterprises have completed the CDE registration of olodaterol active pharmaceutical ingredients (APIs), some of which are in the A status. The original preparation and 3 domestic generic preparations 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 olodaterol impurity reference standards, which comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet various reference standard needs in the stages of API R&D, quality research and registration application.