Pinaverium Bromide

Irritable bowel syndrome, as a common clinical functional gastrointestinal disease, has a global prevalence of approximately 11%. Patients often suffer from recurrent symptoms such as abdominal pain and disordered defecation habits, and there has been a long-term lack of symptomatic medication with both targeting property and safety in clinical practice. Pinaverium bromide is a gastrointestinal selective calcium antagonist. It exerts an antispasmodic effect by inhibiting calcium influx in gastrointestinal smooth muscle and reducing the hyperresponsiveness of smooth muscle. It does not penetrate the blood-brain barrier to cause central adverse reactions, and is one of the few gastrointestinal targeted antispasmodic drugs currently available. In addition to the symptomatic treatment of irritable bowel syndrome, it can also improve pain related to biliary dysfunction and serve as preoperative preparation for barium enema examination, covering the population with gastrointestinal dysfunction of all age groups in adults.

At present, the global pinaverium bromide market size has exceeded USD 320 million, and the compound annual growth rate in the past three years has remained at 4.1%. The growth momentum mainly comes from the increase in the penetration rate of diagnosis and treatment of functional gastrointestinal diseases in primary medical care. In the domestic market, the original research product still accounts for approximately 62% of the market share. With the advancement of the consistency evaluation of generic preparations, generic drugs from 3 domestic enterprises have been approved for marketing. After pinaverium bromide tablets were included in the provincial centralized procurement catalogs of multiple provinces in 2022, the terminal price dropped by 58%, and the overall market dosage increased by 72% compared with that before the centralized procurement.

The original research enterprise of pinaverium bromide is Solvay Pharma of France, with the original trade name "Dicetel". The core compound patent of pinaverium bromide expired in Europe and the United States in 2007, and the Chinese compound patent expired in 2009. The original dosage form is tablet with a specification of 50mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and is also a reference preparation collected by FDA. Up to now, there are 4 pinaverium bromide API registration information on the API Registration Platform of China Center for Drug Evaluation (CDE), among which 2 are in status A (activated and available for marketing), and 6 domestic enterprises have obtained marketing approval for pinaverium bromide tablets. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pinaverium bromide API. Most products support spot supply, and spot 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, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.