Choline fenofibrate

Dyslipidemia is a core controllable risk factor for cardiovascular diseases such as atherosclerosis and coronary heart disease. In clinical lipid-regulating therapy, in addition to statins, the intervention value of fibrates in the treatment of hypertriglyceridemia is irreplaceable. Choline fenofibrate is a third-generation fibrate lipid-regulating drug and a prodrug of phenoxyaromatic acid derivatives. After entering the body, it activates peroxisome proliferator-activated receptor α (PPARα) to regulate lipoprotein metabolic pathways, reduce serum triglyceride and low-density lipoprotein cholesterol levels, and increase high-density lipoprotein cholesterol at the same time. It is mainly used for the treatment of primary hypercholesterolemia and mixed dyslipidemia in adults, especially suitable for people with statin intolerance or dyslipidemia dominated by elevated triglycerides.

In the global lipid-regulating drug market, fibrates account for approximately 8%. The global market size of choline fenofibrate was approximately USD 470 million in 2023, with a compound annual growth rate of 3.2% in the past three years. The growth momentum mainly comes from the demand for combined medication brought about by the rising prevalence of metabolic syndrome. At present, the market of this variety is still dominated by the original research product, with generic drugs accounting for approximately 35%. The Chinese market is still in the introduction period. At present, only 2 enterprises have obtained approval for the marketing of generic preparations, the supply gap of API is large, and it has not been included in the national centralized procurement catalog.

The original research enterprise of choline fenofibrate is AbbVie Inc. of the United States, with the trade name TRICOR®. Its core compound patent in the United States expired in 2018, and the compound patent in China expired in 2020. The main dosage forms approved by the original research are tablets, with specifications of 48mg and 145mg. They have been included in the FDA Reference Listed Drug Catalog, and are also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. As of now, the China CDE API Registration Platform has included a total of 3 registration numbers for choline fenofibrate, of which 2 are in Status A (can be used in domestically marketed preparations), and 4 domestic enterprises have obtained approval for the marketing of choline fenofibrate tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for choline fenofibrate, covering a total of 17 process impurities and degradation impurities. Most of the products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of the Chinese Pharmacopoeia and relevant FDA regulations, and can directly support the full-process R&D needs such as impurity research, quality standard establishment, and generic drug consistency evaluation.