Four Chinese Pharma Giants Secure Simultaneous First-to-File Approval for $2B+ Hemostatic Drug Eltrombopag Olamine Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Today, according to the announcement on the NMPA official website,Jiangsu Aosaikang Pharmaceutical Co., Ltd., Zhengdatianqing Pharmaceutical, Qilu Pharmaceutical, Sichuan KelunSubmitted Category 4 Generic Chemical DrugsEltrombopag Ethanolamine TabletsApproved and deemed to have passed the consistency evaluation, four companies successfully obtained the first generic version of this drug on the same day.
Screenshot source: NMPA official website
Eltrombopag Ethanolamine Tablets(Product Name:Promacta/Revolade）Original Research fromNovartis, is a non-peptide thrombopoietin receptor（TPO-R）Agonist, first approved by the FDA in 2008 for marketing, is used to treat chronic immune-related conditions that have previously responded poorly to treatments such as glucocorticoids and immunoglobulins.(Idiopathic)Thrombocytopenia（ITP）, becoming the world's first oral drug for this indication. Apart from ITP,Eltrombopag Ethanolamine TabletsIndications already approved in the United States also include chronic liver disease with thrombocytopenia and aplastic anemia.. It is reported that,Eltrombopag Ethanolamine TabletsSales continued to grow, with global revenue reaching $2.088 billion in 2022.
In China,NovartisOfEltrombopag Ethanolamine TabletsEntered the market in 2017(Product Name: Revolade), and the indications have been gradually expanded. In 2023On February 24, a new indication for this drug was approved for the treatment of patients with severe aplastic anemia who have had an insufficient response to prior immunosuppressive therapy. CurrentlyRevolade has been included in the medical insurance.(Category B)In 2022, the hospital's internal sales exceeded 370 million yuan.
Source of screenshot: PharmaCloud China Hospital Sales Database
According to the PharmaCloud database, Jiangsu Aosaikang Pharmaceutical Co., Ltd. was the first to submit a generic application for this drug variety in January 2020. In July 2020, Chia Tai Tianqing Pharmaceutical also submitted a generic application. Subsequently, Qilu Pharmaceutical and Sichuan Kelun Pharmaceutical submitted their generic applications in 2021. These four companies were the earliest to submit generic applications for this drug variety, and today they have been approved simultaneously, securing the first generic approval.
Currently, nine pharmaceutical companies, including Shandong Jingwei Pharmaceutical, Zhejiang Hisun Pharmaceutical, and Grand Pharmaceutical, have submitted generic applications for this variety, all of which are under review and approval.
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