Levodropropizine

For intractable dry cough caused by upper respiratory tract infection, bronchitis and other conditions, traditional central antitussives are often accompanied by adverse reactions such as drowsiness and addiction, and there has been a long-standing clinical demand for antitussive drugs with high efficacy and low toxicity. Levodropropizine is a peripheral antitussive. It selectively acts on the C-fiber peripheral receptors in the trachea and bronchi, and inhibits the release of cough-causing mediators such as substance P and neuropeptides, thereby blocking the peripheral conduction pathway of the cough reflex arc without central inhibitory effect. This drug is suitable for dry cough and irritable cough caused by acute upper respiratory tract infection, chronic bronchitis, pneumonia and other diseases, and is friendly to medication users who need to stay awake such as elderly patients and drivers, with tolerance far superior to similar central antitussives.

The global market size of levodropropizine is approximately USD 180 million, with a projected compound annual growth rate of 4.2% from 2023 to 2028. The growth momentum mainly comes from the rising prevalence of chronic respiratory diseases and the increasing clinical demand for non-addictive antitussives. China is the core producer of levodropropizine API, with production capacity accounting for more than 65% of the global total. Under the market pattern where the patent has expired, the competition of generic preparations is sufficient. After the drug was included in local centralized procurement in 2022, the annual demand for its API increased by 37% compared with that before the centralized procurement.

The original research enterprise of levodropropizine is Dompe Farmaceutici S.p.A. of Italy, with the original brand name Levotuss. The core compound patent expired globally in 2003. The main dosage forms of the original product include oral solution, tablets and sustained-release capsules, with common specifications of 60 mg tablets and 60 mg/10 ml oral solution. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, at present, 7 enterprises have obtained Class A status for their levodropropizine APIs through CDE registration, and a variety of dosage forms of generic drugs including tablets, oral solutions and sustained-release capsules have been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for levodropropizine API, which can meet the impurity research needs of different production processes. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, providing stable technical support for enterprises' API registration and declaration, quality research and production process control.