Ge Long Hui·2025-07-29 11:03Core Viewpoint - Jiangsu Hechen Pharmaceutical Co., Ltd. has had its application for the market launch of Ilaprazole enteric-coated tablets accepted, indicating a growing competition in the proton pump inhibitor (PPI) market, which is currently valued at over 15 billion yuan [1][4]. Group 1: Market Dynamics - The Ilaprazole enteric-coated tablet market has seen significant growth, surpassing 10 billion yuan after being included in the national medical insurance in 2019, with sales stabilizing above 15 billion yuan from 2021 to 2022, and slightly declining to around 13 billion yuan in 2023-2024 [4][18]. - The PPI market in 2024 is expected to be competitive, with Ilaprazole's injection ranking first and the enteric-coated tablet among the top three, showcasing its strong market presence [6]. - The competitive landscape for Ilaprazole is shifting from a single dominant player to multiple competitors, as various companies have submitted applications for generic versions [18]. Group 2: Regulatory and Competitive Landscape - The application for Ilaprazole enteric-coated tablets has been classified as a generic drug, with several companies, including Zhejiang Haoge Pharmaceutical and Jiangsu Hechen Pharmaceutical, involved in the approval process [2][10]. - The first generic application was submitted by Shijiazhuang Zhongnuo Pharmaceutical in October 2023, with expectations for approval in February 2025, marking the beginning of intensified competition in the generic market [8][12]. - A total of 13 companies have submitted applications for Ilaprazole enteric-coated tablets, indicating a robust interest in this segment of the pharmaceutical market [12][14]. Group 3: Intellectual Property and Innovation - The patents for Ilaprazole compound and enteric-coated tablets have expired, allowing for increased competition in the market, while other formulations like Ilaprazole injections have patents expiring in 2036 and micro-pellets in 2040 [14][16]. - The ongoing competition in the PPI market is expected to drive improvements in drug accessibility and quality, benefiting patients through enhanced treatment options [18].