Gadobutrol

The clinical diagnosis of central nervous system magnetic resonance imaging (MRI) is highly dependent on safe and efficient contrast agents. As the core variety of the second-generation macrocyclic gadolinium contrast agents, gadobutrol has become a common choice in this field by virtue of its dual advantages of high relaxation rate and high stability. Its mechanism of action is that after gadolinium ions are chelated with the macrocyclic ligand butrol, the relaxation time of hydrogen protons in tissues can be shortened, and the contrast of MRI images can be significantly enhanced. It is suitable for the detection of central nervous system lesions in adults and children of all ages (including full-term newborns), and has outstanding clinical value especially in the qualitative and localized diagnosis of areas with damaged blood-brain barrier, as well as tumors, inflammations and vascular lesions.

The global market size of gadobutrol has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.28 billion, with a compound annual growth rate of around 5%. The growth rate of the Chinese market is higher than the global average. In 2023, its market size was approximately RMB 1.87 billion, with a compound annual growth rate of up to 8%. In terms of the competitive landscape, the original research product accounts for about 65% of the global market share. Domestic generic drug enterprises have gradually achieved technological breakthroughs. As of 2024, generic drug preparations from 3 enterprises have passed the consistency evaluation. Driven by the volume-based procurement policy, the terminal price has dropped by more than 60% compared with the peak price of the original research product, and the accessibility continues to improve.

The original research enterprise of gadobutrol is Bayer HealthCare, and the original research trade name is Gadovist. The core compound patent of gadobutrol expired in 2021 in the United States and Europe, and expired in 2022 in China. The main dosage form approved for the original research product is injection, with specifications of 7.5ml, 10ml and 15ml all at 1.0mmol/ml. It has been included in the China Listed Chemical Drug Catalogue and the FDA Reference Listed Drug Catalogue, and is the legal reference preparation for the domestic仿制 of gadobutrol preparations. In terms of API registration, as of October 2024, there are 6 gadobutrol registration entries on the CDE API registration platform, among which 2 are original research import registrations and 4 are production registrations of domestic enterprises. 3 of the entries are in status A, which can be used in association with domestic preparation applications. A number of domestic generic gadobutrol injections have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of gadobutrol impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and registration declaration.