Omadacycline

In the clinical treatment of infectious diseases such as acute bacterial skin infections and community-acquired bacterial pneumonia, the emergence of drug-resistant bacteria has always been the core barrier to breakthroughs in therapeutic efficacy, and the launch of omadacycline provides a brand-new treatment option for such drug-resistant bacterial infections. As a novel aminomethylcycline subclass of tetracycline antibiotics, it binds to the 30S subunit of bacterial ribosomes and blocks the attachment of tRNA to inhibit bacterial protein synthesis, and maintains favorable antibacterial activity against multidrug-resistant bacteria such as methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae. It is clinically used for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults, and is particularly suitable for patient groups at risk of drug-resistant bacterial infection or those who do not respond to other conventional antibacterial drug treatments.

At present, the global omadacycline market is in a stage of steady growth. The global market size was approximately USD 320 million in 2023, and the compound annual growth rate is expected to remain around 7% by 2029. The Chinese market is still in the early stage of cultivation. Due to the relatively near expiration date of the originator patent, currently only the originator formulation has been approved for marketing in China, and there is no marketing application for generic drugs. The supply of active pharmaceutical ingredients (APIs) is still dominated by the originator's supporting system. With the advancement of layout by generic drug enterprises after the patent expires in the future, the market demand for upstream APIs and related impurity reference standards will show a significant upward trend.

The originator enterprise of omadacycline is Paratek Pharmaceuticals in the United States, and the originator brand name is Nuzyra. Its compound patent expires in 2031 in the United States and in 2030 in China. The dosage forms approved by the originator include injection (100 mg) and oral tablet (150 mg). The originator formulations have been included in the FDA Reference Listed Drug Catalog. In 2021, the originator omadacycline for injection and omadacycline tablets were approved for marketing in China. At present, no enterprise has submitted registration information of omadacycline API in the API registration database of China Center for Drug Evaluation (CDE), and no generic drug formulation has been approved in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of omadacycline impurity reference standards, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable and reliable reference standard support for drug R&D, quality research and generic drug consistency evaluation.