Roflumilast

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high disability rate. For a long time, bronchodilators have been the core of clinical treatment regimens, but their intervention effect on airway inflammation is limited. Roflumilast is the world's first approved and marketed selective phosphodiesterase 4 (PDE4) inhibitor. It reduces the release of inflammatory mediators by inhibiting PDE4 activity, and precisely acts on the chronic inflammatory pathway of COPD. It is mainly used to treat severe COPD patients with frequent acute exacerbations or those with chronic bronchitis symptoms. It can effectively reduce the frequency of acute exacerbations and improve patients' lung function and quality of life, and is an important drug option that fills the gap in targeted anti-inflammatory therapy.

The global roflumilast market size has maintained a steady growth trend in recent years. In 2023, the global market size was approximately USD 1.87 billion, and the compound annual growth rate from 2024 to 2030 is expected to be approximately 3.8%. From the perspective of competitive landscape, the original research product still dominates the European and American markets. In the domestic market, the popularity of generic drug applications has continued to rise since the patent expiration. At present, roflumilast preparations from more than 10 domestic enterprises have been approved for marketing. The implementation of centralized procurement has further promoted the improvement of product accessibility. On the upstream API side, domestic enterprises have gradually realized production capacity substitution, and roflumilast is an API variety in the respiratory field with relatively fast domestic substitution progress.

The original research enterprise of roflumilast is AstraZeneca, and the original research trade name is Daxas®. The expiration time of its core compound patent in the United States is 2015, and the expiration time of the core compound patent in China is 2019. The main dosage form approved for the original research product is tablet, with a specification of 0.5mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, roflumilast APIs from more than 8 enterprises have obtained CDE registration numbers at present, most of which are in Status A and can be marketed and sold in China. Corresponding to these APIs, multiple domestic generic preparations have been approved for marketing after passing the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for quality research and compliance declaration of roflumilast, CATO can provide a full set of impurity reference standards for this 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 reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process quality control needs of pharmaceutical enterprises from API R&D to marketing declaration.