Dimenhydrinate

Motion sickness is a highly prevalent vestibular dysfunction disorder that occurs in people's travel scenarios, with a global prevalence rate of over 30%. In scenarios such as long-distance travel and riding special vehicles, its incidence rate can rise to more than 50%, which significantly reduces travel experience and even affects the work performance of people engaged in special operations. Dimenhydrinate is an anti-motion sickness drug belonging to the H1 receptor antagonist category. It exerts its effect by inhibiting central vestibular function and reducing gastrointestinal smooth muscle spasm. As a first-line over-the-counter anti-motion sickness drug in current clinical practice, it can be used to prevent and treat nausea and vomiting caused by carsickness, seasickness and airsickness, and is applicable to adults and children over 6 years old, making it a common category in the global list of household standby medicines.

The global market size of anti-motion sickness drugs was approximately USD 1.87 billion in 2023. With definite efficacy and good safety, dimenhydrinate accounts for nearly 27% of the market share of over-the-counter anti-motion sickness drugs, with a compound annual growth rate maintained at around 4.2%. For the domestic market, dimenhydrinate preparations have been included in the Category B over-the-counter drug catalogue, and can be sold through multiple channels such as retail pharmacies and supermarkets. There are more than 60 existing production approvals, and the market is dominated by generic drugs, with leading enterprises accounting for about 31% of the market share. This variety has not been included in the centralized procurement scope yet, so the market competition is relatively sufficient.

The original research enterprise of dimenhydrinate is Bayer AG of the United States, with the original brand name Dramamine. The core compound patent expired globally in 1987. The main dosage forms of the original research product launched include tablets and sustained-release capsules, with common specifications of 25mg and 50mg. Its 50mg conventional tablet has been included in the FDA Reference Listed Drug Catalogue, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs (11th Batch)* of China. As of September 2024, the dimenhydrinate active pharmaceutical ingredients (APIs) of 22 domestic enterprises have obtained Class A status through CDE registration. The approved preparation varieties for marketing cover three categories: tablets, buccal tablets and sustained-release capsules, among which buccal tablets are a dosage form unique to China. (Data as of September 2024, please refer to the official CDE website for the latest information)

For API manufacturers and preparation R&D enterprises, impurity research is the core link in the product declaration and quality control of dimenhydrinate. CATO can provide a full set of dimenhydrinate impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of enterprises in different scenarios such as R&D, quality testing and registration declaration.