Rizatriptan

Migraine is the most common type of primary headache in clinical practice, with a global prevalence of over 14%. The pulsating pain, photophobia and phonophobia and other symptoms accompanying the attack seriously affect patients' daily work and life. Traditional non-steroidal anti-inflammatory drugs have limited effect in relieving moderate to severe attacks. Rizatriptan belongs to the second generation of triptan anti-migraine drugs. By highly selectively agonizing the 5-HT1B/1D receptors on the intracranial vascular wall and trigeminal nerve endings, it inhibits abnormal vasodilation and neurogenic inflammatory response, and can quickly relieve headache and accompanying symptoms within 30 minutes. It is suitable for the treatment of acute migraine attacks in adults and children aged 6 to 17 years, and is currently the first-line drug for the acute phase treatment of migraine.

At present, the global market size of rizatriptan is stably maintained at around USD 700 million, and the Chinese market has maintained an annual growth rate of around 8% in recent years. The core driving forces are the improvement of migraine diagnosis rate and the standardization of clinical medication. In terms of the competitive landscape, the original research product accounts for nearly 35% of the global market share, while the domestic generic drug market is dominated by 3 leading enterprises. After this variety was included in the national centralized procurement in 2021, the price of preparations dropped by more than 70%, and the cost control demand of downstream preparation enterprises increased, driving the acceleration of the localization substitution process of upstream API.

The original research enterprise of rizatriptan is Merck Sharp & Dohme, with the original brand name MAXALT (Ouliting). The core compound patent expired in 2012 in the United States, and the Chinese compound patent expired in 2010. The main dosage forms approved by the original research include conventional tablets and orally disintegrating tablets, with specifications of 5mg and 10mg. The original research products have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the reference preparation catalogue of the FDA. In terms of domestic API registration, 7 enterprises have obtained approval for their rizatriptan APIs through the CDE associated review so far. The rizatriptan preparations approved for marketing in China cover two dosage forms: tablets and orally disintegrating tablets, with a total of 12 approval numbers. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of rizatriptan impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API and preparation enterprises in quality research and consistency evaluation work.