Dicloxacillin

In the clinical treatment of drug-resistant bacterial infections, penicillinase-resistant semi-synthetic penicillins have always been one of the core medication options, and dicloxacillin is a representative variety of this category. It binds to bacterial penicillin-binding proteins to inhibit cell wall synthesis, while its own structure can resist the hydrolysis and destruction of β-lactamases. It has a potent bactericidal effect on Gram-positive bacteria such as penicillinase-producing Staphylococcus aureus, and is clinically mainly used to treat respiratory tract infections, skin and soft tissue infections, urinary tract infections and bone and joint infections caused by susceptible bacteria, especially suitable for patients with penicillin-resistant staphylococcal infections. It is a commonly used basic drug for infection diagnosis and treatment in primary and specialized medical institutions.

The global dicloxacillin market size has maintained a steady growth trend for a long time. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate maintained at around 3.1%. The demand growth mainly comes from the release of infection diagnosis and treatment demand in primary medical institutions and the expansion of applications in the animal health field. The domestic market is a typical mature generic market. More than 20 enterprises have obtained preparation approval documents, and the supply of APIs is mainly from local manufacturers. The price of selected preparations in centralized procurement has dropped by more than 60%, and the cost control and quality compliance of upstream APIs have become the core competitive elements for downstream preparation enterprises. There are no publicly verifiable segmented market share data at present.

The original research enterprise of dicloxacillin is Pfizer, and the original research trade name is Diclocil. Its core compound patent expired globally in 1981, and there is no core patent restriction at present. The main dosage forms approved for the original research product include oral tablets, capsules and dry suspensions, with common specifications of 250mg and 500mg. Its 250mg tablet has been included in the FDA Reference Listed Drug Catalog, and the original research product has not yet been included in the *List of Chemical Drugs* in China. According to the domestic API registration platform, 8 enterprises have obtained A-status registration numbers for dicloxacillin APIs, and domestic dicloxacillin capsules and tablets have been approved for marketing for many years, with sufficient clinical accessibility. (Data as of October 2025, please refer to the official website of CDE for the latest information)

In response to the quality research and compliance needs of dicloxacillin, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable support for the quality control and impurity research work of API manufacturers and preparation R&D institutions.