Tigecycline

Multidrug-resistant bacterial infection has become a core challenge in global clinical anti-infective therapy, especially infections caused by carbapenem-resistant bacteria, for which clinically available drugs are extremely limited. As a third-generation tetracycline broad-spectrum antibacterial agent, tigecycline binds to the 30S subunit of bacterial ribosomes, blocks aminoacyl-tRNA from entering the A site of ribosomes, and inhibits bacterial protein synthesis. It has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobes and even atypical pathogens. Clinically, it is mainly used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia in patients aged 18 years and above, and is an important alternative for the treatment of multidrug-resistant bacterial infections.

The global market size of tigecycline maintains a steady growth trend, with the market size reaching approximately USD 480 million in 2023, with a compound annual growth rate of approximately 3.2%. In terms of the domestic market, the sales volume of tigecycline at the terminal of public medical institutions in 2024 was approximately RMB 1.27 billion. Affected by the centralized procurement policy, the market share of generic drugs has exceeded 90%, and the market share of original research products has been gradually compressed. Domestic manufacturers are dominated by leading generic pharmaceutical enterprises, with a relatively high industry concentration.

The original research enterprise of tigecycline is Pfizer, with the original brand name Tygacil. The expiration date of its compound patent in the United States is 2023, and the compound patent in China expired in 2016. The original dosage form is injection, with a specification of 50mg (calculated as C29H39N5O8), which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, nearly 20 enterprises have obtained A status for their tigecycline APIs through CDE registration. A number of domestic enterprises have obtained approval for the marketing of tigecycline for injection, which have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for tigecycline API. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the demand for impurity reference standards in various stages such as API R&D, quality research, and consistency evaluation.