Iobitridol

The popularization of cardiovascular intervention and imaging diagnosis technologies has put forward higher requirements for the safety of non-ionic iodinated contrast agents. Iobitridol is a third-generation low-osmolar non-ionic dimeric iodinated contrast agent, which achieves imaging by absorbing X-rays after administration via blood vessels or lumens. Its osmotic pressure is close to that of plasma, and its neurotoxicity and vascular irritation are significantly lower than those of traditional ionic contrast agents. It is clinically mainly used for adult cardiovascular angiography, urography, intravenous pyelography and CT enhanced scanning of head, chest, abdomen and other parts, especially suitable for elderly patients with underlying diseases and poor tolerance to contrast agents.

The global iobitridol market size has maintained a steady growth rate of around 4% in recent years, and the market size in 2023 was approximately USD 180 million. The growth rate of the domestic market is slightly higher than the global average, remaining at around 6%. At present, the original research products still occupy the main market share in the domestic market, and 3 domestic enterprises have submitted applications for the marketing of generic drugs. With the advancement of the centralized procurement policy related to contrast agents, the market share of domestic generic preparations is showing a gradual upward trend.

The original research enterprise of iobitridol is GUERBET of France, and the original research trade name is Xenetix®. The expiration time of its core compound patent in Europe is 2013, and the compound patent in China has expired in 2012. The main dosage form approved for the original research product is injection, including two common specifications of 300mgI/ml and 350mgI/ml, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, 2 domestic enterprises have obtained A-status registration numbers for their iobitridol API through the review and public announcement of CDE, and another 6 enterprises have obtained marketing approval for their generic iobitridol injection products. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for iobitridol API. 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 the Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for the consistency evaluation of generic drugs, quality research and impurity control in the production process.