Phenobarbital

Central nervous system depressant drugs have been in clinical application for nearly a century. Among them, barbiturates, with their well-defined sedative and anticonvulsant effects, remain a basic medication option for nervous system diseases such as epilepsy to date. As a representative long-acting barbiturate, phenobarbital exerts its effect by enhancing the function of γ-aminobutyric acid, an inhibitory neurotransmitter in the central nervous system, to reduce neuronal excitability. Clinically, it is mainly used for the treatment of generalized and partial seizures of epilepsy, and can also be used for the prevention and control of convulsions caused by febrile convulsions and hypoxic-ischemic encephalopathy in neonates. It is one of the commonly used drugs for the treatment of childhood epilepsy, and has also been included in the National Essential Medicines List to ensure clinical accessibility.

Driven by factors such as the stable prevalence of epilepsy and the continuous release of drug demand in primary medical institutions, the domestic phenobarbital market size maintains a steady growth trend. In 2023, the overall market size was approximately RMB 420 million, with a compound annual growth rate maintained at around 3.1%. Due to the early marketing time of the drug, the current domestic market is dominated by generic drug supplies, with a high concentration of manufacturers. The API segment is mainly supplied by 3 to 5 domestic pharmaceutical companies, and nearly 20 approvals have been granted for the preparation segment. After the coverage of centralized procurement, the product price tends to be stable, and the clinical supply is sufficient without obvious supply gaps.

The original developer of phenobarbital is Bayer AG of Germany, with the original brand name Luminal, which was first approved for marketing in 1912, and the core compound patent has expired worldwide. At present, the main dosage form of the original product is tablet, with specifications including 15mg, 30mg and 100mg, which has been included in the FDA Reference Listed Drug Catalog, and the original preparation has not been imported into China for the time being. In terms of domestic API registration, 5 enterprises have had their phenobarbital APIs publicly announced via CDE registration numbers (status A) up to now. Domestic preparation approvals are mainly for small-specification tablets, and fully localized supply has been realized. (Data as of September 2024, please refer to the official CDE website for the latest information.)

In response to the impurity analysis needs in the process of generic drug development and quality control of phenobarbital, CATO provides a full set of impurity reference standards for this API, which can cover all categories of analysis needs such as process impurities and degradation impurities. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support the full-process R&D work of pharmaceutical enterprises such as methodological validation, stability study and quality standard establishment.