Qilu Pharma Secures Approval for $1.8 Billion Antithrombotic Drug Edoxaban Tosylate Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On January 13, 2025, according to the latest information on the NMPA's official website,Qilu PharmaceuticalSubmitted Generic Drug Category 4Edoxaban Tosylate TabletsApproved and considered to have passed the evaluation, the original research of this variety has occupied the majority of the domestic hospital market in China, with a share as high as 98.56%.
Screenshot source:NMPA OfficialNet
EdoxabanDeveloped by Daiichi Sankyo, it is a new type of anticoagulant drug that directly targets coagulation factor Xa. The product was approved in China in 2018 and successfully entered the 2020 National Medical Insurance Catalogue, Category B, through price negotiations, starting to achieve rapid market penetration. According to the Morexin Pharma Database,EdoxabanGlobal sales exceeded $1.8 billion in 2023, with a year-on-year growth of 4.20%.
Screenshot source:Moxie Medicine Global Drug R&D Database
In the Chinese market,Edoxaban Tosylate TabletsIn 2024（Q1-Q3）Sales within hospitals across China are approaching 300 million yuan. Of this, the original research product occupies a market share as high as 98.56%, firmly holding the top position in the market; closely following is Hainan Simcere Pharmaceutical, with a market share of 1.41%, ranking second.
Screenshot source:Moxie Pharma (formerly Yaoke Rongyun)National Hospital Sales Database
As of now,Edoxaban Tosylate TabletsFive pharmaceutical companies, including Hainan Simcere Pharmaceutical, Qilu Pharmaceutical, Shanghai Desano Medicine Group, Shandong New Era Pharmaceutical, and Cisen Pharmaceutical, have been approved and passed the evaluation. In June 2021, Hainan Simcere Pharmaceutical submitted a Category 4 generic drug application.Edoxaban Tosylate TabletsThe listing application was the first in China; in September 2022, the product was approved for marketing as the first domestic generic and the first to pass the evaluation. This time, Qilu Pharmaceutical has become the fifth Chinese manufacturer.
Screenshot source:Moxie Pharma Approved Drugs Summary Database
Qilu Pharmaceutical Secures Win in 2024Eltrombopag Ethanolamine Tablets, Entrectinib Tablets, Metformin Empagliflozin Tablets (VI), Riociguat Tablets, Tafamidis Meglumine Soft Capsules, Bendamustine Hydrochloride Concentrated Solution for Injection, Apalutamide TabletsSeven products are the first generics, ranking at the top of the industry. At the start of the new year in 2025, Qilu Pharmaceutical (including subsidiaries) has already...Cefoperazone Sodium and Sulbactam Sodium for Injection, Edoxaban Tosylate Tablets, Ibrutinib Tablets, Roxadustat CapsulesThe passing of the consistency evaluation for four generic drugs further consolidated its leading position in the generic drug market.
Edoxaban Tosylate TabletsAs a new type of anticoagulant drug that directly acts on coagulation factor Xa, it has demonstrated strong growth momentum in both international and Chinese markets. In the Chinese market, the original product occupies the majority share, but with the successive approval and market entry of domestically produced generic drugs, the competitive landscape is gradually changing. Domestic pharmaceutical companies such as Qilu Pharmaceutical Co., Ltd., with their robust research and development capabilities and market competitiveness, have achieved remarkable success in the field of generic drugs, injecting new vitality into the domestic market. In the future, with the addition of more domestically produced generic drugs,Edoxaban Tosylate TabletsThe market competition will become more intense, while also providing patients with more choices and better treatment options.
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