Avibactam

In response to the clinical treatment dilemma of multidrug-resistant Gram-negative bacterial infections, the combination regimen of β-lactamase inhibitors and antibiotics has become a core medication option. Avibactam, as a new generation of non-β-lactam β-lactamase inhibitor, can reversibly inhibit Class A, Class C and part of Class D β-lactamases. When used in combination with antibiotics such as ceftazidime and imipenem, it can effectively restore the susceptibility of pathogenic bacteria to drugs. At present, it is mainly used for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired pneumonia and ventilator-associated pneumonia, especially for adult patients with carbapenem-resistant bacterial infections, providing key support for the clinical treatment of drug-resistant bacterial infections.

In 2023, the domestic market size of avibactam-related compound preparations has exceeded 5 billion yuan, with a compound annual growth rate of more than 35% in the past three years. Driven by the promotion of hierarchical diagnosis and treatment and the rising incidence of drug-resistant bacterial infections, the market size will continue to maintain a rapid growth trend. In terms of the competitive landscape, the original research product accounts for nearly 60% of the market share, and more than 10 domestic enterprises have been approved for generic drugs. With the expansion of the scope of centralized procurement, the market share of generic drugs is steadily increasing, and the demand for localization of active pharmaceutical ingredients continues to be released.

The original research enterprise of avibactam is Pfizer, and the trade name of its original research compound preparation is Zavicefta (ceftazidime and avibactam). The core compound patent of avibactam will expire in 2027 in China, and the preparation patent will expire in 2030. The marketed original research dosage form is injection, with a specification of 2.5g (2g ceftazidime and 0.5g avibactam), which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, nearly 20 domestic enterprises have completed the registration of avibactam active pharmaceutical ingredients in CDE, and more than 30 approved compound preparation varieties such as ceftazidime avibactam and imipenem avibactam have been obtained. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of avibactam impurity reference standards. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process requirements of active pharmaceutical ingredient research and development, quality research and daily production quality control.