Ranolazine

As a common chronic cardiovascular disease, chronic angina pectoris has long relied on conventional treatments such as β-receptor blockers and calcium channel blockers for a long time, but some patients still have clinical pain points of poor symptom control and limited tolerance. Ranolazine is a piperazine class of anti-anginal drug, whose mechanism of action is different from that of traditional drugs. By selectively inhibiting the late sodium current, it reduces calcium overload in myocardial cells, improves myocardial energy metabolism without affecting heart rate and blood pressure, and relieves angina symptoms. It is clinically mainly used as second-line treatment for chronic stable angina pectoris. It can be used as a single agent for patients intolerant to traditional drugs, and can also be used in combination with conventional therapeutic drugs to improve symptom control effect. The applicable population covers adult patients with chronic stable angina pectoris.

Data show that the global ranolazine-related market size in 2023 was approximately USD 420 million. Driven by the rising prevalence of cardiovascular diseases and the increasing demand for medication among the elderly population, the compound annual growth rate from 2024 to 2028 is expected to remain at around 3.1%. In terms of competitive landscape, after the core patent of the original research product expired, the proportion of generic drugs has continued to increase, and currently accounts for nearly 65% of the global market; the Chinese market is still in the early stage of generic drug substitution, with fewer than 10 domestic generic drug manufacturers approved for marketing, and the overall market still has considerable growth potential.

The original research manufacturer of ranolazine is Kite Pharma under Gilead Sciences of the United States? No, oh, it is CV Therapeutics, which was later acquired by Gilead, and the original research trade name is Ranexa. Its core compound patent in the United States expired in 2019, and the core patent in China also expired in 2019. The main dosage form of the original research product is sustained-release tablets, with specifications including 500mg and 1000mg. The original research sustained-release tablets have 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, more than 15 enterprises have completed the registration of ranolazine APIs in the CDE (status A) so far, and multiple domestic ranolazine sustained-release tablets have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of ranolazine impurity reference standards. Most products are available in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for API R&D, quality research and consistency evaluation links.