Rotigotine

As a common degenerative disease of the central nervous system, Parkinson's disease has a prevalence rate of 1.7% among people aged over 65. Middle and late stage symptoms such as dyskinesia and motor fluctuations severely reduce the quality of life of patients. Rotigotine is a non-ergot dopamine receptor agonist, which continuously stimulates dopamine D3/D2/D1 receptors to simulate physiological dopamine secretion. It is currently the only anti-Parkinson's disease drug that can be administered via transdermal patch. It is suitable for monotherapy in patients with early-stage Parkinson's disease, can also be combined with levodopa to improve motor symptoms in patients with middle and late stage disease, and can be used to relieve restless legs syndrome, especially suitable for patients with dysphagia and poor gastrointestinal absorption.

The global rotigotine market size was approximately USD 1.28 billion in 2023, with a compound annual growth rate of 4.2% in the recent five years. The core growth drivers come from the continuous increase in the number of Parkinson's disease patients worldwide, as well as the rising acceptance of transdermal administration among elderly patients. The domestic market is still in the initial stage of growth. In 2023, the sales volume at the terminal of public medical institutions was approximately RMB 210 million, with a year-on-year increase of 27.6%. Currently, the original research product accounts for more than 90% of the market share, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the successive approval of generic drugs after patent expiration, the market penetration rate is expected to further increase.

The original research enterprise of rotigotine is UCB (Germany), and the original trade name is Neupro. Its compound patent in China expires in 2025, the core European patent expired in 2022, and the US patent expires in 2026. The original dosage form is transdermal patch, covering 4 specifications: 2mg/24h, 4mg/24h, 6mg/24h and 8mg/24h. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs (2nd Batch)* of China, and also included in the FDA Reference Preparation Catalogue. As of June 2025, there are 6 registration entries of rotigotine API on the CDE API registration platform, among which 2 are in status A; the original transdermal patch and 2 domestic generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of rotigotine impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation.