Naratriptan

Migraine is the most common primary headache type in clinical practice, with a global prevalence rate of over 10%, and moderate to severe attacks can seriously affect patients' daily work and life. As first-line drugs for the acute treatment of migraine, triptans selectively agonize 5-HT1B/1D receptors, inhibit the release of neuropeptides from the trigeminal nerve, and constrict cerebral blood vessels, thereby rapidly relieving headache and accompanying symptoms such as nausea and photophobia. Naratriptan belongs to the second-generation triptan drugs. Compared with the first-generation sumatriptan, it has a half-life of up to 6 hours, a longer duration of action, and a lower migraine recurrence rate. It is particularly suitable for adult patients with long headache duration and high previous recurrence rate, and can also be used for the preventive treatment of menstruation-related migraine.

The global market size of naratriptan is approximately USD 320 million. In recent years, affected by the rising prevalence of migraine and the increasing demand of patients for long-acting treatment, the compound annual growth rate has remained at 4.1%. As the core patents have long expired, the global market is dominated by generic drug supply, and the market share of original research products is less than 15%. The domestic market is still in the early cultivation stage. At present, the annual sales volume at the terminal of public medical institutions is approximately RMB 12 million. With the improvement of migraine diagnosis and treatment rate and the approval of more generic drugs, the market growth rate is expected to exceed 12% in the next 3 years.

The original research enterprise of naratriptan is GlaxoSmithKline, with the original research brand name Naramig, and the core compound patent expired globally in 2010. The main approved dosage form of the original research product is tablet, with a specification of 2.5mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (10th Batch)* in China. Up to now, there is no approved naratriptan preparation product on the market in China, and there is no naratriptan registration number in status A on the CDE API registration platform for the time being. Only the registration applications submitted by 2 enterprises are in the review and approval status. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of naratriptan impurity reference standards. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock. Spot orders paid before 16:00 can be shipped on the same day, which can fully meet various reference standard needs for API research and development, quality research and generic drug consistency evaluation.