Atogepant

As a neurological disease with a high global burden, migraine has seen the use of traditional triptans limited in populations at high cardiovascular risk due to their vasoconstrictive side effects, while the advent of calcitonin gene-related peptide (CGRP) receptor antagonists has brought a safer option for the acute treatment of migraine. Atogepant is an oral small-molecule CGRP receptor antagonist, which exerts its effect without relying on vasoconstrictive mechanisms by highly selectively blocking the binding of CGRP to its receptor and inhibiting neurogenic inflammation and pain signal transduction. It is clinically indicated mainly for the acute treatment of migraine with or without aura in adults, and can also be used for the preventive treatment of episodic migraine, especially suitable for patients with underlying cardiovascular comorbidities who cannot tolerate triptans.

Currently, the global market size of acute migraine treatment has exceeded 6 billion US dollars, among which CGRP receptor antagonist drugs maintain a compound annual growth rate of over 35%, becoming the fastest-growing segment. As the first oral CGRP receptor antagonist simultaneously approved for both acute treatment and preventive treatment indications, atogepant has seen a rapid increase in market share after launch, with global sales exceeding 1.7 billion US dollars in 2023. At present, the original research product still holds a dominant position in major markets, and multiple pharmaceutical companies in many countries including China have launched generic drug research and development. With the expiration of core patents one after another, the accessibility of generic drugs will be greatly improved after their launch in the future.

The original research manufacturer of atogepant is Pfizer, with the original brand name Ubrelvy. Its US compound patent will expire in 2029, and the core compound patent in China is valid until 2031. The main dosage form approved for the original product is tablet, with specifications including 50mg and 100mg, which has been included in the FDA Reference Listed Drug Catalog. The China NMPA approved the import and marketing of the original tablet in 2024. As of the retrieval time, there is no approved domestic atogepant API registration number on the CDE API registration platform, and generic drug preparations of domestic pharmaceutical companies are still in the clinical trial or application stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of atogepant impurity reference standards, which fully cover impurities from the synthesis process, degradation impurities and process by-products, all complying with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are in sufficient stock, and spot orders submitted before 16:00 can be shipped on the same day, which can fully meet various needs in the generic drug R&D stage, such as qualitative and quantitative impurity research, quality standard establishment and stability study.