Pitavastatin

Cardiovascular disease is one of the disease categories with the highest fatality rate globally. As a core inducing factor of cardiovascular disease, the clinical control of dyslipidemia is highly dependent on statin lipid-regulating drugs. Pitavastatin belongs to the third-generation statin HMG-CoA reductase inhibitor. It competitively inhibits the key enzyme in cholesterol synthesis, effectively reducing the level of low-density lipoprotein cholesterol (LDL-C), and also has a certain regulatory effect on triglycerides. Compared with previous generations of statins, it requires a lower therapeutic dose, and has a lower incidence of adverse reactions such as muscle toxicity and elevated liver enzymes. It is mainly used for the treatment of adult patients with hypercholesterolemia and familial hypercholesterolemia, and is also applicable to the dyslipidemia population intolerant to other statins, and it is a first-line lipid-regulating drug recommended by guidelines.

Driven by the rising prevalence of dyslipidemia and the upgrading of clinical medication demand, the global market size of pitavastatin has grown steadily in recent years, which exceeded US$900 million in 2023, and the market size in China is approximately RMB 1.8 billion, with a compound annual growth rate maintained at around 7%. The competition pattern of the domestic market is dominated by generic drugs. At present, more than 20 enterprises have obtained approval for pitavastatin generic drug preparations. After it was included in the fourth batch of national centralized procurement in 2021, the price of preparations has dropped by more than 80%, the market penetration rate has further increased, and the demand for upstream APIs continues to be released. The domestic API supply is dominated by local enterprises, and the accessibility has been greatly improved.

The original research enterprise of pitavastatin is Kowa Co., Ltd. of Japan, and the original brand name is "Livalo". Its core compound patent expired in Japan in 2008, and the core patent expired in the United States in 2018, while the compound patent in China expired in 2007. The originally marketed dosage forms include tablets with specifications of 1mg and 2mg, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and are also reference preparations recognized by the FDA. As of October 2024, there are more than 30 pitavastatin API registration information on the API registration platform of China CDE, most of which are in status A. A number of domestic enterprises have obtained approval for the marketing of pitavastatin calcium tablets and pitavastatin dispersible tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of pitavastatin impurity reference standards, covering various impurities generated during the synthesis and degradation processes. Most products are available in stock. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in different scenarios such as R&D, quality control, and registration declaration.