Tedizolid

Infection caused by drug-resistant Gram-positive bacteria is a long-standing difficulty in clinical anti-infective treatment. In particular, skin and soft tissue infections and pneumonia caused by pathogenic bacteria such as methicillin-resistant *Staphylococcus aureus* (MRSA) and vancomycin-resistant enterococci (VRE) often lead to poor prognosis of patients due to limited optional drugs. Tedizolid is a second-generation oxazolidinone antibacterial agent, which exerts antibacterial activity by inhibiting the protein synthesis of the 50S subunit of bacterial ribosomes. Compared with the first-generation drugs of the same category, it has a longer half-life, lower dosage, and significantly lower risk of adverse reactions such as myelosuppression. It is mainly used for the treatment of acute bacterial skin and skin structure infection (ABSSSI) in patients aged 18 and above, and is also recommended by guidelines for sequential treatment of drug-resistant Gram-positive bacterial infections.

At present, the global tedizolid market size maintains a steady growth trend. The overall market size in 2023 is about USD 320 million, with a compound annual growth rate of around 7%. From the perspective of competitive landscape, the original research product still occupies the main market share. The domestic market has long relied on imported preparations before, and generic drugs have been gradually approved for marketing after 2021. At present, a total of 6 domestic enterprises have submitted marketing registration applications for tedizolid active pharmaceutical ingredients (APIs), and generic preparations from 3 enterprises have passed the consistency evaluation. As the volume-based procurement scope gradually covers new antibacterial drugs, the clinical accessibility of this variety is expected to be further improved.

The original research enterprise of tedizolid is Cubist Pharmaceuticals, a subsidiary of Merck & Co., Inc., and the original research trade name is Sivextro. Its compound patent in the United States expires in 2024, and the compound patent in China expires in 2025. The main dosage forms approved for the original research product include injections and oral tablets. The specification of the injection is 200 mg per vial, and the specification of the tablet is 200 mg per tablet. The original research preparation has been included in the *Catalogue of Chemical Reference Preparations* issued by the NMPA, and is also included in the FDA Reference Preparations Catalogue. Up to now, there are 8 domestic registration numbers for tedizolid APIs, of which 6 have been converted to A status and can be supplied for domestic preparation production. In addition, tedizolid phosphate tablets and tedizolid phosphate for injection from 5 manufacturers have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full range of tedizolid impurity reference standards, covering process impurities, degradation impurities and isotope-labeled substances, which fully meet the impurity research requirements of pharmacopoeias of various countries. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation.