Revefenacin

Chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic respiratory disease, and bronchodilators are the core medication option in its long-term management. Revefenacin belongs to the long-acting muscarinic antagonist (LAMA) class of drugs. It competitively blocks the M3 receptors on airway smooth muscles to relax bronchial smooth muscles, thereby achieving the effects of sustained airway dilation and relieving airflow limitation. Only once-daily administration is required to maintain the bronchodilator effect for 24 hours. It is clinically mainly used for the long-term maintenance treatment of COPD patients, which can significantly reduce the risk of acute exacerbations in patients, improve lung function and exercise tolerance, and is particularly suitable for middle-aged and elderly stable COPD patients who require long-term regular medication.

Revefenacin has shown a significant market growth trend since its launch. In 2023, its global market size has exceeded 900 million US dollars, and the compound annual growth rate in the past three years has remained above 18%. At present, the global market is still dominated by the original research product, while the domestic market is still in the introduction stage, with only a small number of generic drug companies in the declaration stage. With the continuous increase in the number of COPD patients in China and the increase in the clinical penetration rate of long-acting bronchodilators, the domestic market has great growth potential in the future.

The original research enterprise of revefenacin is Shire, an American company, with the original research trade name Yupelri. The expiration date of the core compound patent in the United States is 2030. The main dosage form approved for the original research product is inhalation solution, with the specification that each 1.75ml vial contains 175μg of revefenacin. This preparation has been included in the FDA Reference Listed Drug Catalog. As of now, there is no approved and marketed revefenacin preparation in China, and the relevant DMF registration of its API is still blank. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for revefenacin API. Most products are in stock. All in-stock products ordered before 16:00 can be shipped on the same day. All products fully meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference requirements in the process of drug research and development, quality research and production.