Frovatriptan

Migraine is a recurrent neurovascular disease with a global prevalence of more than 10%, and moderate to severe attacks can seriously affect patients' daily work and life. Frovatriptan is a second-generation selective serotonin (5-HT1B/1D) receptor agonist. By agonizing 5-HT1B/1D receptors on intracranial blood vessels and sympathetic nerves of the trigeminal nervous system, it inhibits excessive dilation of cerebral blood vessels and reduces the release of neuropeptides, thereby relieving the symptoms of migraine attacks. Meanwhile, it can also alleviate the adverse reactions associated with migraine such as nausea and photophobia. It is mainly used for the acute treatment of migraine with or without aura in adults, and is especially suitable for patient groups with long attack duration and high recurrence rate.

At present, the global market size of triptan drugs is about US$ 3 billion. Frovatriptan, with its clinical advantages of long half-life (about 26 hours) and low migraine recurrence rate, accounts for about 3% of the market share, with an annual growth rate of around 4%, which is higher than the average growth rate of first-generation triptan drugs. The domestic market is still in the introduction stage. At present, only a few enterprises have laid out the generic R&D of this variety, and the annual sales volume at the terminal of public medical institutions is about RMB 12 million. With the improvement of migraine diagnosis and treatment rate, the market size is expected to exceed RMB 50 million in the next 3 years.

The original research enterprise of frovatriptan is Veridian Pharmaceuticals, an Irish enterprise, with the original brand name Frova. The core compound patent expired in the United States in 2021, and the Chinese compound patent has expired. The main dosage form approved for the original drug is tablet, with a specification of 2.5mg, which has been included in the FDA Reference Listed Drug Catalog, but has not been included in the Chinese *Catalog of Reference Listed Drugs for Chemical Preparations* yet. There is no API registration information of this variety in China, and no domestic preparation has been approved for marketing for the time being. Only the original imported preparation was approved for marketing by the National Medical Products Administration in 2023. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of frovatriptan impurity reference standards. Relevant products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in regular stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet various supply needs of enterprises in the stages of generic drug R&D and quality research.

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