Fexofenadine

Allergic diseases are among the highly prevalent chronic diseases worldwide. Second-generation antihistamines have become the first-choice basic antiallergic drugs for clinical use due to their low central inhibitory side effects. As a representative of the third-generation H1 antihistamines, fexofenadine is the active metabolite of terfenadine. It can selectively block peripheral H1 receptors and inhibit the release of inflammatory mediators from mast cells. It has no anticholinergic effect or cardiotoxicity, and will not cause adverse reactions such as drowsiness and dizziness. Clinically, it is mainly used for the symptomatic treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children over 6 years old. It can quickly relieve symptoms such as nasal itching, sneezing, rash and pruritus, and has good long-term medication safety, especially suitable for patient groups who need long-term control of allergic symptoms and have high requirements for work alertness.

At present, the global market size of antihistamines has exceeded 8 billion US dollars. As a first-line clinical drug, fexofenadine accounts for about 15% of the global market share of second-generation antihistamines, with a compound annual growth rate maintained at 3.2%. In the domestic market, the annual sales of fexofenadine preparations exceed 1.2 billion yuan. With the annual increase in the prevalence of allergic diseases, there is still room for steady growth in demand. In terms of the competitive landscape, the original research product accounts for about 30% of the market share. More than 20 domestic enterprises have been approved to produce generic preparations. After centralized procurement, the price of preparations has dropped by more than 60%, driving the rapid increase in demand for upstream API. At present, the domestic API supply is dominated by local enterprises, and the overall competition is relatively sufficient.

The original research enterprise of fexofenadine is Sanofi-Aventis, with the original brand name "Allegra". Its US compound patent expired in 2025, and its core Chinese patent expired in 2024. The main dosage forms approved for the original research include tablets, capsules and oral suspensions, with common specifications of 30mg, 60mg, 120mg and 180mg, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. In terms of domestic API registration, 11 enterprises have obtained CDE registration numbers for fexofenadine API, among which 8 have been activated with A status. 23 generic preparations have been approved for marketing in China, covering common dosage forms such as tablets and capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for fexofenadine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises in quality research, impurity calibration, application and registration, etc.