Dabigatran Etexilate is an oral anticoagulant drug used for the prevention of thrombus and embolus formation after major orthopedic surgery (hip or knee replacement) and for the prevention of stroke in people with non-valvular atrial fibrillation and other embolisms of the body circulation.
Dabigatran etexilate is a precursor drug of dabigatran that is enzymatically hydrolyzed in vivo to the coagulant-active dabigatran, which exerts its anticoagulant effect through direct inhibition of thrombin. Dabigatran etexilate mesylate capsules, originally developed by Boehringer Ingelheim under the trade name of Pradaxa®, were approved for marketing by EMA in March 2008 and then approved by FDA in 2010. After the launch, its sales value peaked at USD1.60 billion in 2013. The sales value then started to decrease due to the launch of other competitive anticoagulants like rivaroxaban and apixaban.
In March 2013, Dabigatran etexilate capsules were approved in China for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, under the trade name of Taibiquan® with the specifications of 110 mg/capsule and 150 mg/capsule. In 2017, Dabigatran etexilate immediate-release formulation for oral use has been included in the Category B drugs in the latest China National Reimbursement Drug List. In March 2020, Chia Tai Tianqing’s generic dabigatran etexilate capsules were approved by the NMPA for marketing in China, followed by Jiangsu Hansoh Pharmaceutical and Chengdu Easton Bio Pharmaceuticals in early 2021. And It is expected that, from 2021 to 2025, more generic dabigatran etexilate drugs will be approved.
According to CRI’s market research, the sales value of dabigatran etexilate in China declined to approximately CNY329 million (USD50.6 million) in 2020 due to COVID-19. And China’s dabigatran etexilate market was entirely dominated by Boehringer Ingelheim International GmbH before 2020. Despite the launch of Chia Tai Tianqing’s dabigatran etexilate in 2020, Boehringer Ingelheim International GmbH still held more than 99% share of the dabigatran etexilate market in China in terms of sales value. It is expected that Boehringer Ingelheim International GmbH’s share of China’s dabigatran etexilate market will decline for more generic products will become available.
- Impact of COVID-19 on China’s Dabigatran Etexilate Market
- Development Environment of Dabigatran Etexilate in China
- Sales Volume of Dabigatran Etexilate in China
- Sales Volume and Value of Dabigatran Etexilate in China by Region
- Major Dabigatran Etexilate Manufacturers in China and Their Market Shares
- Sales Price of Dabigatran Etexilate in China
- Prospects of China’s Dabigatran Etexilate Market, 2021-2025