Qilu Pharmaceutical Submits Application for Dronedarone Hydrochloride Tablets, a $400M Antiarrhythmic Drug

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On April 9, the official website of the National Medical Products Administration showed,Qilu Pharmaceutical's Market Application for Generic Class 4 Dronedarone Hydrochloride Tablets Accepted by CDE.Currently, only one company in China has been approved to produce the generic version of Dronedarone Hydrochloride Tablets.

Source: National Medical Products Administration

Dronedarone is a Class III antiarrhythmic drug., a benzofuran derivative that optimizes the structure of amiodarone, is a structural analog of amiodarone designed to eliminate its non-cardiovascular adverse effects. Clinically, it is mainly used for rhythm control in patients with paroxysmal or persistent atrial fibrillation (AF) / atrial flutter (AFL), reducing the recurrence of AF/AFL.

Dronedarone was developed by Sanofi (trade name: Multaq), It was launched in the United States and Europe in 2009. According to Sanofi's financial report,Global Sales of Multaq Exceeded $400 Million in 2022。

Currently, only the original developer Sanofi and Shijiazhuang Pharma Group Ouyi Pharmaceutical Co., Ltd. have launched dronedarone tablets for sale in China.

In 2015,Shiyao OuyiDronedarone Hydrochloride Tablets (400mg) reported for production as a Class 3.1 new drug, were included in the priority review process in 2016, and finallyApproved for marketing in October 2019, capturing the first domestic generic drug approval in China., applicable to patients with sinus rhythm who have a history of paroxysmal or persistent atrial fibrillation, reducing the risk of hospitalization due to atrial fibrillation (AF).Sanofi's original product was approved for marketing in China in December 2021, with the trade name Multaq.

In recent years, several companies have successively reported the production of Dronedarone Hydrochloride Tablets according to Category 4 generics.Jiangxi Kerui Pharmaceutical、Shijiazhuang SiyaoAndQilu PharmaceuticalThree companies submitted listing applications,Jiangsu Litai'er Pharmaceutical、Shandong New Era Pharmaceutical Co., Ltd.Submitted listing applications in 2022 and 2023, respectively.