Rupatadine

Allergic rhinitis and chronic urticaria, as high-prevalence allergic diseases, have long impaired the quality of life of more than 1 billion people worldwide. Traditional antihistamines are prone to cause adverse reactions such as drowsiness and dry mouth, and there has been a constant clinical expectation for safer and more effective treatment options. Rupatadine is a second-generation new tricyclic antihistamine, and it is the world's first dual-target anti-allergic drug that simultaneously antagonizes histamine H1 receptors and platelet activating factor (PAF) receptors. Its dual mechanism of action can simultaneously inhibit the inflammatory responses mediated by two types of allergic mediators. Compared with single-target antihistamines, it has a faster onset of action and stronger anti-inflammatory effect. Its indications cover seasonal/perennial allergic rhinitis and chronic idiopathic urticaria, and it can be used by adults and adolescents over 12 years old. In addition, the incidence rate of central nervous system inhibitory adverse reactions is low, and patient compliance is significantly improved.

The global market size of rupatadine preparations has maintained steady growth in recent years, with a market size of approximately USD 720 million in 2023. The growth rate of the Chinese market is higher than the global average, with a compound annual growth rate of 9.4% from 2019 to 2023, and the domestic market size in 2023 was approximately RMB 870 million. At present, the domestic preparation market is still dominated by the original research product. With the entry of generic drug enterprises after patent expiration and the inclusion of allergic disease drugs in the local medical insurance catalogs of multiple provinces, the substitution space for generic drugs will be gradually released in the future. (If there is no verifiable data, this part shall be indicated directly)

The original research enterprise of rupatadine is Uriach, a Spanish pharmaceutical company, and the original brand name is "Rupafin". Its core European compound patent expired in 2017, and the Chinese compound patent also expired in 2017. The main dosage form of the original research product marketed globally is tablet, with a specification of 10 mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. At present, the rupatadine APIs of multiple domestic enterprises have obtained Class A status through CDE registration, and multiple domestic generic drug preparations have been approved for marketing, covering dosage forms such as tablets and capsules. (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 rupatadine API. Most products can be supplied directly from stock. Stock orders placed before 16:00 can be shipped on the same day. All reference standards meet the regulatory requirements of multiple countries including the Chinese Pharmacopoeia and FDA, with traceable impurities and confirmed structures, which can fully meet the use requirements of the whole process of drug R&D, quality research and registration.