Pivmecillinam

Urinary tract infection is an infectious disease with a high incidence worldwide. The emergence of drug-resistant bacteria has led to a continuous increase in clinical demand for β-lactam drugs with high oral tolerance and stable antibacterial activity. As a semi-synthetic penicillin derivative, pivmecillinam is the pivalate ester of mecillinam. After oral administration, it can be rapidly hydrolyzed by esterases in the body into the active ingredient mecillinam, which exerts a bactericidal effect by specifically binding to bacterial penicillin-binding protein PBP2 and inhibiting bacterial cell wall synthesis. It has high activity against Gram-negative bacteria, especially common pathogenic bacteria of urinary tract infection such as Escherichia coli, Klebsiella pneumoniae and Proteus. It is clinically mainly used for uncomplicated urinary tract infection caused by sensitive bacteria, and can also be combined with other antibacterial drugs for the treatment of complicated urinary tract infection and respiratory tract infection, and is suitable for various infected populations such as children and adults.

At present, the global market size of pivmecillinam is approximately US$ 320 million, with a compound annual growth rate of 4.7% in the past three years. The growth momentum mainly comes from the increase in the diagnosis and treatment penetration rate of urinary tract infection in primary medical institutions and the release of demand for empirical treatment of drug-resistant bacterial infections. In terms of the domestic market, this variety has not yet been included in the national centralized procurement. At present, there are fewer than 5 approved preparation manufacturers, and there is still a large space for domestic substitution on the API supply side. At this stage, the pivmecillinam preparations used in domestic clinics are still dominated by imported products, and the R&D enthusiasm for generic drugs has gradually increased since 2022, and the corresponding demand for APIs and impurity reference substances has also risen.

The original research enterprise of pivmecillinam is LEO Pharma Denmark, with the original brand name "Negaban". Its core compound patents expired in the European and US markets in 2002 and 2003 respectively. The main dosage forms of the original marketed products are tablets and capsules, with two specifications of 200mg and 400mg. Among them, the original 200mg tablet has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Catalogue of Marketed Drugs in China. Up to now, no domestic enterprise has been approved to market pivmecillinam API, and there is no relevant A status registration number on the CDE API registration platform. Only 2 imported original tablets obtained the domestic import drug registration approval in 2019. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the current demand for impurity research in the process of pivmecillinam generic drug R&D, CATO can provide a full set of impurity reference standards for this API. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as drug quality research and registration declaration.