Cloxacillin

For infectious diseases caused by penicillin-resistant staphylococci, clinical practice has long faced the treatment dilemma of resistance to common β-lactam drugs. As a representative variety of isoxazole-class semi-synthetic penicillins, cloxacillin exactly fills this clinical gap. Its mechanism of action is to block the hydrolysis of β-lactamase through the steric hindrance of the side chain, so as to maintain the antibacterial activity against enzyme-producing staphylococci. Clinically, it is mainly used for the treatment of septicemia, respiratory tract infections and soft tissue infections caused by enzyme-producing Staphylococcus aureus, and can also be used for mixed infections of pyogenic streptococci and penicillin-resistant staphylococci. The applicable population covers adult and pediatric patients with sensitive bacterial infections.

At present, the global market size of cloxacillin is approximately USD 320 million, with a stable compound annual growth rate of 2.8% in the recent three years. The demand growth mainly comes from the popularization of anti-infective drugs in primary medical institutions and the antibacterial demand in the animal husbandry and breeding field. In the domestic market, generic drugs account for more than 90% of the supply share, among which API enterprises in North China and East China are the main suppliers. After the implementation of volume-based procurement in recent years, the price of preparations has dropped by 47%, which further drives the annual growth of upstream API demand by about 12%. There is no publicly verifiable source for relevant market data.

The original research enterprise of cloxacillin is AstraZeneca, with the original research trade name "Orbenin", and its core compound patent expired globally in 1981. At present, the mainstream dosage forms include cloxacillin sodium for injection (0.25g, 0.5g, 1.0g), oral capsules (250mg, 500mg) and dry suspension (125mg/5ml). The original research preparations have been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for cloxacillin APIs, and another 28 enterprises have obtained marketing approval for cloxacillin preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for cloxacillin, fully covering process impurities, degradation impurities and reference substances required for stability studies. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and compliance declaration.