Doripenem

Multidrug-resistant bacterial infections have become a core challenge in global clinical anti-infective therapy. Carbapenem antibiotics serve as a vital line of defense against such infections. Among them, doripenem belongs to the carbapenem subclass of β-lactam drugs. It exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria including Pseudomonas aeruginosa and other multidrug-resistant strains. Clinically, it is mainly used for the treatment of moderate to severe infections such as adult complicated intra-abdominal infections, complicated urinary tract infections (including pyelonephritis), and hospital-acquired pneumonia (including ventilator-associated pneumonia). It is applicable to patients with drug-resistant bacterial infections for whom other antibacterial drugs are ineffective, and is an important treatment option in the field of severe infections.

The global market size of doripenem has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.27 billion, with a compound annual growth rate of around 3.2%. From the perspective of the competitive landscape, the original research product still occupies the major share of mature markets such as Europe, the United States and Japan, while the penetration rate of generic drugs in emerging markets such as Asia Pacific and Latin America is increasing year by year. China is the main production base of generic doripenem. At present, a number of enterprises have obtained preparation approvals, and the production capacity of APIs accounts for more than 60% of the global generic drug market supply. After the implementation of the centralized procurement policy, the price of domestic preparations has dropped by more than 70%, which further improves the accessibility of the drug and drives the continuous rise in the demand for upstream APIs.

The original research enterprise of doripenem is Shionogi & Co., Ltd. of Japan, with the original brand name "Finibax". The core compound patents of doripenem expired in 2015, 2016 and 2017 in Japan, the United States and Europe respectively, and the compound patent in China expired in 2014. The main dosage form approved by the original research is powder for injection, with two specifications of 0.25g and 0.5g, which has been included in the U.S. FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (29th Batch)*. As of now, there are 12 registration entries of doripenem API on the China CDE API registration platform, among which 8 are in Status A (can be used in marketed preparations). In China, 11 enterprises have obtained marketing approval for doripenem for injection preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for doripenem API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the whole process of API R&D, quality research, consistency evaluation, etc., helping enterprises accelerate the R&D and declaration process.