Tulobuterol

Bronchial asthma is a chronic inflammatory airway disease with a large patient population that requires long-term maintenance treatment. Tulobuterol is a representative variety of highly selective β2-adrenoceptor agonist anti-asthmatic drugs. It acts by agonizing β2 receptors on airway smooth muscle, relaxing bronchial smooth muscle and inhibiting the release of inflammatory mediators. Meanwhile, it can promote the movement of respiratory cilia to help sputum discharge. Its clinical indications cover respiratory diseases accompanied by bronchospasm such as bronchial asthma, acute/chronic bronchitis, and emphysema. It has good application safety for both adult and pediatric asthma patients. Compared with non-selective β receptor agonists, the incidence of cardiac adverse reactions is significantly reduced.In the current domestic anti-asthmatic drug market, the annual market size of long-acting β2 receptor agonists has exceeded 2.5 billion yuan, with an annual compound growth rate maintained at around 8%. Among them, tulobuterol has multiple dosage forms such as oral administration and transdermal patches, so its market growth rate has stabilized at 11% in the past 3 years, which is higher than the average level of the category. In terms of the competitive landscape, the domestic preparation market is dominated by generic products, and the market share of original research products is less than 20%. At present, more than 12 domestic enterprises have obtained preparation approvals, and the localization rate of API has reached more than 90%, without a market pattern of monopoly by a single enterprise.The original research enterprise of tulobuterol is Japan's Kyorin Pharmaceutical Co., Ltd., and the original research trade name is "Hokunalin". The expiration time of its core compound patent in major markets such as Japan and the United States is 2007, and the compound patent in China has expired in 2006. The main dosage forms approved for the original research include 1mg tablets and 2mg transdermal patches. The patch dosage form has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China. At present, there are 23 relevant registration numbers for tulobuterol API in China, among which 18 are in A status. The corresponding approved preparations cover three categories: tablets, patches and aerosols, with a total of 17 preparation approvals. (Data as of June 2025, please refer to the official website of CDE for the latest information)CATO provides a full set of impurity reference standards for tulobuterol API, which can fully meet the impurity research needs of the current mainstream domestic API production processes. Most of the 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 including the Chinese Pharmacopoeia and FDA, and can directly support the full-process research from API declaration to preparation consistency evaluation.

目前国内平喘类药物市场中，长效β2受体激动剂年市场规模已突破25亿元，年复合增长率保持在8%左右，其中妥洛特罗因兼具口服、透皮贴等多种给药剂型，近3年市场增速稳定在11%，高于品类平均水平。竞争格局方面，国内制剂市场以仿制产品为主，原研产品市场占比不足20%，目前已有超过12家国内企业获得制剂批文，原料药国产化率已达90%以上，未出现单一企业垄断的市场格局。

妥洛特罗原研企业为日本杏林制药，原研商品名为“Hokunalin”，其核心化合物专利在日本、美国等主要市场的到期时间为2007年，中国境内化合物专利已于2006年过期。原研获批的主要剂型包括1mg片剂及2mg透皮贴剂，其贴剂剂型已列入FDA参比制剂目录，国内未进口原研制剂，目前国内已有23个妥洛特罗原料药相关登记号，其中18个为A状态，对应获批制剂涵盖片剂、贴剂、气雾剂三类，共有17个制剂批文。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技提供妥洛特罗API全套杂质标准品，可完全匹配当前国内主流原料药生产工艺的杂质研究需求，大部分产品现货供应，现货产品16:00前下单当天发货，产品符合中国药典、FDA多法规合规要求，可直接支持从原料药申报到制剂一致性评价的全流程研究使用。