Terbutaline

Bronchial asthma is a highly prevalent chronic airway inflammatory disease with more than 300 million patients worldwide, and the acute spasm symptoms of nearly half of these patients cannot be rapidly relieved by short-acting β receptor agonists. Terbutaline is a selective β₂ adrenoceptor agonist, which can relax bronchial smooth muscle, inhibit the release of endogenous sensitizing substances, reduce mucosal edema and improve ciliary movement function by activating β₂ receptors on the surface of airway smooth muscle cells. It is clinically mainly used for the treatment of bronchial asthma, chronic bronchitis, obstructive emphysema and other pulmonary diseases accompanied by bronchospasm, with the applicable population covering adult, pediatric and elderly patients with cough and asthma, and it is one of the first-line emergency medications for the acute attack stage of asthma.

The global terbutaline market size was approximately USD 820 million in 2023, and the compound annual growth rate is expected to reach 4.3% by 2028. The growth momentum mainly comes from the improvement of the diagnosis and treatment coverage of chronic respiratory diseases at the primary level and the expansion of the demand for medications for pediatric wheezing diseases. In terms of the domestic market, the terminal sales of terbutaline in public medical institutions exceeded RMB 1.2 billion in the first half of 2024, among which inhalation solutions accounted for more than 85%. At present, 17 domestic generic preparation enterprises have obtained approval, and terbutaline has been included in the seventh batch of national centralized procurement. The selected price has decreased by more than 70% compared with that of the original research drug, further reducing the medication burden of patients.

The original research enterprise of terbutaline is AstraZeneca, with the trade name of "Bricanyl". Its core compound patent expired in major global markets in 2008, and the preparation patent in China also expired in 2011. The main dosage forms approved for the original research drug include terbutaline sulfate inhalation solution (2ml:5mg), tablets (2.5mg) and aerosol (0.25mg/puff). Among them, the inhalation solution has been included in the Reference Listed Drug Catalog of the China Listed Medicines Catalog, and is also included in the FDA Reference Listed Drug Catalog. Up to now, there are 23 registration records of terbutaline sulfate on the API registration platform of China Center for Drug Evaluation (CDE), among which 11 have been activated with A status, which can support the associated review and approval of domestic preparations. More than 30 terbutaline preparation varieties have been approved for marketing in China. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for terbutaline API. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are in sufficient stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in the stages of R&D, quality research and commercial production.