Ceftibuten

Lower respiratory tract infections such as community-acquired pneumonia and acute bronchitis are common clinical bacterial infectious diseases, and the rising pathogen resistance has always been a core challenge in treatment. Ceftibuten is a third-generation oral cephalosporin antibiotic, which exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. Its antibacterial activity against Gram-negative bacteria is significantly superior to that of most second-generation oral cephalosporins, and it is highly stable to β-lactamase. Clinically, it is mainly used to treat respiratory tract infections, urinary tract infections and gastrointestinal tract infections caused by sensitive bacteria, and is applicable to adult patients and pediatric patients over 6 months old. The convenience of oral administration endows it with high clinical value in sequential therapy and community infection prevention and control.

The global market size of ceftibuten was approximately USD 120 million in 2023, with a compound annual growth rate maintained at around 3.2%. The growth mainly comes from the increased demand for oral high-efficiency antibacterial drugs in the primary medical market. At present, the domestic market is dominated by generic drug supplies. There are a total of 3 preparation enterprises that have passed the consistency evaluation, and the overall competition pattern is relatively concentrated. The annual sales volume at public medical institution terminals is stable at around RMB 230 million, of which oral dosage forms account for more than 98%.

The original research enterprise of ceftibuten is Merck Sharp & Dohme, and the original trade name is "Cedax". Its core compound patent expired in the United States in 2003, and the relevant compound patents in China have expired and become invalid. The main dosage forms approved for the original research are capsules (200mg, 400mg) and dry suspensions (36mg/ml, 90mg/5ml). Both the original capsules and dry suspensions have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. As of now, there are a total of 6 ceftibuten API registration records on the API Registration Platform of China Center for Drug Evaluation (CDE), among which 3 have obtained A status after passing the joint evaluation and approval with preparations. The domestically approved ceftibuten preparations for marketing include two dosage forms, namely capsules and dry suspensions, both of which have generic drugs approved for supply. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of ceftibuten impurity reference standards, which can fully cover the requirements for impurity qualitative and quantitative research and quality compliance verification in the R&D process. Most products are in stock. In-stock products ordered before 16:00 can 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 effectively assist API and preparation enterprises in quality control throughout the whole process of R&D, registration and production.