Butalbital

In the field of medications for central nervous system diseases, barbiturates still hold a stable clinical position due to their well-defined sedative and hypnotic effects, and butalbital is a representative medium-acting barbiturate. It acts on the γ-aminobutyric acid A receptor, prolongs the opening time of chloride channels, and inhibits the excitability of central nervous system neurons, thereby exerting the pharmacological effects of sedation, hypnosis and anti-anxiety. In clinical practice, it is often formulated into compound preparations with paracetamol, caffeine and other ingredients for relieving tension headache and symptoms during migraine attacks, and is applicable to adult headache patients without severe respiratory insufficiency and no history of allergy to barbiturates.

The global market size of compound preparations containing butalbital is approximately USD 320 million, with a compound annual growth rate maintained at 1.8% in the past 3 years. The growth momentum mainly comes from the stable release of the demand for symptomatic headache medications in primary medical institutions. The market is dominated by generic drugs, with the market share of original research products accounting for less than 15%. At present, no imported butalbital preparations have been approved for marketing in China, and the preparation R&D of local enterprises is still in the early stage. The supply of active pharmaceutical ingredients (APIs) is temporarily dominated by overseas imports, and there is no publicly verifiable data on the domestic market size.

The original research enterprise of butalbital is Novartis, with the original brand name Fioricet (compound with paracetamol and caffeine). The core compound patent of butalbital expired globally in 1990. The main dosage form of the original research product marketed is oral capsule, with the specification of 50mg butalbital/325mg paracetamol/40mg caffeine. This compound preparation has been included in the FDA Reference Listed Drug Catalog. Up to now, no valid registration number of butalbital has been found in the API registration database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and no domestic or imported single-agent or compound preparations of butalbital have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of butalbital impurity reference standards, covering process impurities and degradation impurities that may be generated during the synthesis process. Most products have sufficient in-stock reserves, and in-stock orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various usage needs in the stages of API R&D, quality research and registration application.