Ubrogepant

Migraine is a common chronic neurological disease worldwide. The recurrent throbbing headache accompanied by nausea, photophobia and other symptoms seriously affects patients' daily work and life. Ubrogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist. It blocks the binding of CGRP to its receptor with high selectivity, thereby inhibiting neurogenic inflammation and pain signal transduction related to migraine attacks. It can be used not only for the acute treatment of migraine in adults, but also for the preventive treatment of episodic migraine in adults with at least 4 attacks per month. It breaks through the limitation of cardiovascular adverse reactions of traditional triptans, and provides a safer option for migraine patients with underlying diseases.

At present, the number of migraine patients worldwide exceeds 1 billion, and the market size of acute migraine treatment has exceeded 6 billion US dollars. Among them, the annual compound growth rate of CGRP antagonist drugs exceeds 35%, making it the fastest-growing细分 category in the field of migraine treatment in the past decade. Ubrogepant, as the world's first oral CGRP receptor antagonist approved for both acute treatment and preventive treatment indications, has seen its sales continue to rise after launch, with global sales reaching 1.72 billion US dollars in 2023. The domestic market is still in the introduction period, and a number of pharmaceutical companies have arranged for the research and development of generic drugs. With the continuous release of clinical demand for related indications, the future market growth space is significant.

The original research enterprise of ubrogepant is Pfizer, and the original trade name is Ubrelvy. The core compound patent expires in 2036 in the United States and in 2037 in China. The main dosage form approved for the original research is oral tablet, with specifications of 50mg and 100mg, which has been included in the FDA Reference Listed Drug Catalog. At present, no original ubrogepant preparation has been approved for marketing in China, and no approved A-status registration number of ubrogepant has been found on the CDE API registration platform. The research and development of related generic drugs by domestic pharmaceutical companies is still in the clinical stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of ubrogepant impurity reference standards. Most products are in sufficient stock. Spot orders submitted before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical companies in various stages such as API research and development, quality research, and generic drug declaration.