Metaxalone

Centrally acting muscle relaxants are an important clinical option for relieving pain associated with skeletal muscle spasm. Metaxalone, as a representative variety of this category, exerts its effects by blocking polysynaptic reflexes in the spinal cord and inhibiting the pain conduction pathway of the central nervous system, without affecting the normal contractile function of skeletal muscle. In clinical practice, it is mainly used to relieve skeletal muscle spasm and accompanying pain caused by acute sprain, strain, myofibrositis and other diseases, and is applicable to adult patients with musculoskeletal pain without severe hepatic and renal insufficiency. Due to its relatively mild sedative adverse reaction, it is widely used in outpatient rehabilitation and postoperative pain management in orthopedics.

The global market size of metaxalone is approximately USD 120 million, with a compound annual growth rate of 3.1% in the past three years. The demand growth mainly comes from the rising prevalence of chronic musculoskeletal pain and the expansion of postoperative rehabilitation demand. The competitive landscape presents the characteristic of "originator drug leading, generic drugs supplementing". The United States is the largest consumer market, accounting for 62% of global demand; the domestic market is still in the introduction stage. With the gradual improvement of the clinical pathway for muscle relaxants, the market growth rate is expected to rise to more than 8% in the next three years. There is no publicly verifiable segmented sales data for the domestic market at present.

The originator enterprise of metaxalone is King Pharmaceuticals of the United States, with the originator brand name Skelaxin. The core compound patent expired in 2015, and the latest formulation patent in the US market expired in 2021. The originator dosage form is oral tablet with a specification of 800 mg, which has been included in the FDA Reference Listed Drug Catalog. There is no approved import of the originator formulation in China. As of November 2024, there is no approved metaxalone registration number with A status on the CDE API registration platform. Only one enterprise has submitted a registration application which is in I status, and there is no metaxalone oral formulation variety approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of metaxalone impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for API R&D, quality research and registration declaration.