Doxofylline

In the long-term management of chronic airway diseases, bronchodilators are the core medications for controlling symptoms such as wheezing and dyspnea. As a methylxanthine derivative, doxofylline is an upgraded variety of theophylline drugs. It inhibits the activity of phosphodiesterase, reduces the intracellular calcium ion concentration, relaxes bronchial smooth muscle, and also has anti-inflammatory and immunomodulatory effects. Its anti-asthmatic intensity is 10 to 15 times that of aminophylline, and the incidence of adverse reactions such as central excitation and gastrointestinal irritation is significantly lower. It is mainly used for the treatment of bronchial asthma, chronic obstructive pulmonary disease (COPD), asthmatic bronchitis and other diseases, covering adult and elderly patients with chronic airway diseases.

The domestic doxofylline market scale is growing steadily. In 2023, the market scale was approximately RMB 1.87 billion, with a compound annual growth rate of 7.2% in the recent three years. The demand growth mainly comes from the rising prevalence of COPD and the penetration of the primary medical market. The competition landscape is characterized by the dominance of generic drugs. More than 20 domestic enterprises have obtained approval for doxofylline preparation approvals, and the API supply side is dominated by local enterprises. After the coverage of centralized procurement, the price of preparations has dropped by more than 60%, further promoting the process of clinical replacement of traditional aminophylline.

The original developer of doxofylline is ABC Farmaceutici S.p.A. of Italy, with the original brand name "Ansimar". Its core compound patent expired globally in 2009. The main dosage forms of the original drug include injection (10ml:0.1g), tablet (0.2g) and oral solution. Among them, doxofylline for injection and tablets have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, as of now, 17 enterprises have passed the CDE associated review and approval for doxofylline API (A status). The domestically approved preparation dosage forms cover multiple categories such as injection, powder for injection, tablet, capsule, etc. (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 doxofylline API, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.