Rimegepant

Migraine is a common disabling neurological disease worldwide. Previous acute treatment mostly relied on triptans, but there are limitations such as the risk of cardiovascular adverse reactions and multiple contraindications. The advent of rimegepant has filled this clinical gap. As the world's first oral calcitonin gene-related peptide (CGRP) receptor antagonist, it reversibly blocks the binding of CGRP to its receptor, inhibits neurogenic inflammation and pain signal transduction. It is suitable not only for the acute treatment of migraine in adults, but also for the preventive treatment of episodic migraine in adults, especially for migraine patients who are intolerant to triptans and have combined cardiovascular risk factors.

The number of people suffering from migraine worldwide exceeds 1 billion, driving the market size of rimegepant to continue to rise. In 2023, its global sales exceeded 1.7 billion US dollars, with a compound growth rate of more than 40% in the past three years. At present, the global market is still dominated by the original research product. With the expiration of core patents one after another, the R&D enthusiasm for generic drugs has increased rapidly. No generic drug has been approved for marketing in China yet, and more than 20 enterprises are in the R&D stage. After the implementation of centralized procurement in the future, the price drop is expected to further improve clinical accessibility.

The original research enterprise of rimegepant is Biohaven Pharmaceutical, and the original research trade name is Nurtec ODT. Its core compound patent in the United States expired in 2031, and the validity period of the domestic core compound patent is until 2032. The main dosage form of the original research product is orally disintegrating tablet, with a specification of 75mg, which has been included in the FDA Reference Listed Drug Catalog. At present, it has not been included in the *Catalog of Reference Preparations for Chemical Drugs* in China. There is no approved A-status registration number for rimegepant on the domestic API registration platform for the time being, and the original preparation was approved by NMPA for marketing in China in 2024. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for rimegepant, covering the full-path reference standards such as starting materials, intermediates and degradation impurities in the synthesis process. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems including the Chinese Pharmacopoeia and FDA, and can fully meet the research needs of the whole process such as API R&D, quality research, registration and declaration.