Orlistat

As a chronic metabolic disease with a逐年 rising global prevalence, obesity can induce multiple complications such as hyperlipidemia, hypertension and type 2 diabetes in the long term, and there is a significant gap in the demand for weight loss in long-term clinical management. Orlistat is a specific gastrointestinal lipase inhibitor. It binds to the active serine site of lipase in the stomach and small intestinal lumen, inactivating the enzyme so that it cannot hydrolyze triglycerides in food into absorbable free fatty acids and monoacylglycerol. Undigested fat is excreted from the body with feces, achieving the effects of reducing calorie intake and controlling body weight. This drug is the only approved non-central weight loss drug currently available, suitable for overweight or obese patients with a body mass index ≥ 24, and can also be used for long-term weight management of obese people accompanied by hypertension, diabetes and hyperlipidemia.

In 2023, the global market size related to orlistat was approximately USD 1.87 billion, with a compound annual growth rate maintained at around 7.2%. In terms of the domestic market, the consumer demand for weight loss over-the-counter drugs continues to be released. In 2023, the retail market size of orlistat exceeded RMB 3.2 billion, making it the core variety in the domestic OTC weight loss category currently. The competition landscape is dominated by generic drugs. There are more than 50 approval documents for orlistat preparations in China, and API manufacturers are concentrated in Zhejiang, Guangdong, Jiangsu and other regions. The production capacity of leading enterprises accounts for more than 60%. After winning the bid in centralized procurement, the terminal price of preparations has dropped by more than 70%, further promoting the improvement of product accessibility.

The original research enterprise of orlistat is Roche, and the original research trade name is "Xenical/赛尼可". Its core compound patent expired globally in 2009. The main dosage form approved for the original research product is capsule, with a specification of 120mg, which has been included in the Reference Listed Drug Catalog of China Marketed Chemical Drugs and the Reference Preparation Catalog of the US FDA. According to the domestic API registration platform, there are currently 12 orlistat API registration numbers, 8 of which are in status A (marketable). A variety of dosage forms such as orlistat capsules and tablets have been approved for marketing in China, among which the 120mg capsule is an OTC variety, and the 60mg specification was approved as a Class B over-the-counter drug in 2020. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of orlistat impurity reference standards. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs of API and preparation enterprises, including quality research, stability study and registration declaration.