Piribedil

Parkinson's disease is a common neurodegenerative disease among middle-aged and elderly people. The dual distress of motor fluctuations and non-motor symptoms is a core difficulty in clinical treatment. The advent of piribedil provides differentiated medication options for such patients. As a non-ergot dopamine receptor agonist, it can specifically stimulate dopamine D2 and D3 receptors, and increase cerebral blood flow at the same time. It can be used as a single agent for the initial treatment of early-stage Parkinson's disease to improve core motor symptoms such as tremor and myotonia, and can also be combined with levodopa for patients with middle and advanced stage disease to reduce the occurrence of motor complications. In addition, it is also used to improve intermittent claudication caused by chronic occlusive arterial disease of the lower extremities, as well as for adjuvant treatment of ophthalmic ischemic symptoms, covering multiple patient groups such as those with elderly chronic diseases and peripheral vascular diseases.

The global piribedil market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 320 million, with the Chinese market accounting for about 18%, and the compound annual growth rate remaining at around 4%. Due to the early expiration of the original research patent, the competition in the domestic generic drug market is relatively mild. At present, oral preparations from 3 enterprises have been approved for marketing, and another 5 enterprises are in the generic drug declaration stage. After the implementation of the volume-based procurement policy, the terminal price of this drug has dropped by about 62%, the accessibility for patients has been significantly improved, and the demand in the primary market has been released significantly, driving the annual growth rate of the demand for active pharmaceutical ingredients to exceed 7%.

The original research enterprise of piribedil is Servier of France, and the original research trade name is "Trastal". The core compound patent expired in 2003 in major markets such as Europe and the United States, and the compound patent in China also expired in 2005. The original research dosage form is sustained-release tablet with a specification of 50mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 6 valid DMF numbers for piribedil active pharmaceutical ingredients registered with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, including 4 domestic active pharmaceutical ingredient registration numbers and 2 imported active pharmaceutical ingredient registration numbers. A number of domestic enterprises have obtained approval for marketing of piribedil sustained-release tablets after passing the quality and efficacy consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of piribedil impurity reference standards. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple sets of regulations such as the Chinese Pharmacopoeia and FDA, with complete impurity structure confirmation data, which can provide stable compliance support for active pharmaceutical ingredient R&D, quality research and consistency evaluation.