Sumatriptan

As the world's second most disabling neurological disease, migraine is often accompanied by photophobia, phonophobia, nausea, vomiting and other symptoms during moderate to severe attacks, and traditional analgesic drugs have limited targeted relief effect for most patients. Sumatriptan is an anti-migraine drug belonging to the 5-hydroxytryptamine 1B/1D receptor agonist class. By activating 5-HT receptors on the wall of intracranial blood vessels, it constricts the excessively dilated meningeal blood vessels, and at the same time inhibits the transmission of pain signals in the trigeminal nerve pathway, which can specifically relieve the acute attack of migraine. It is not suitable for the prevention of migraine, and is only recommended for migraine patients over 18 years old without underlying cardiovascular diseases to use on demand.

As the first triptan drug launched in the world, sumatriptan, with its definite targeted efficacy, is still one of the mainstream drugs for the acute treatment of migraine up to now. Globally, the market size of its generic drugs has exceeded 1.8 billion US dollars, with a compound annual growth rate maintained at around 3.2%. The market pattern is dominated by generic drugs, and more than 30 pharmaceutical companies around the world have been approved to market their generic drugs. As for the domestic market, the annual sales of sumatriptan preparations at the terminal of public medical institutions are stable at around 200 million yuan. In recent years, with the improvement of migraine diagnosis and treatment rate, the market growth rate has remained above 7%. At present, 5 domestic enterprises have been approved for its oral preparations, and the winning bid price in centralized procurement has dropped by more than 80% compared with the original research price, further promoting the accessibility of the drug.

The original research enterprise of sumatriptan is GlaxoSmithKline, and the original research trade name is Imitrex. Its core compound patent in the United States expired in 2008, and its compound patent in China expired in 2010. The main dosage forms approved for the original research include tablets (25mg, 50mg, 100mg), nasal sprays (5mg, 20mg) and subcutaneous injections (6mg/0.5ml), among which the oral tablets of 25mg, 50mg and 100mg specifications have been included in the China Listed Drug Catalog as reference preparations. According to the domestic API registration platform, the sumatriptan API registration numbers submitted by 6 domestic enterprises have been approved as Class A status and can be marketed and sold in China, and a number of domestic generic drugs corresponding to the oral preparations have also been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for sumatriptan API, which can match different synthetic process routes and preparation R&D requirements. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.