Ilaprazole: An Effective Choice for Peptic Ulcer Treatment

Market Situation

Ilaprazole raw materials and enteric-coated tablets were developed by Korea's Yuhan Corporation in 2001, and the domestic Lizhu Group introduced the compound technology from this company in 2002, subsequently applying for research and development. It was approved for market release in December 2007 under the brand name Yilian, marking its global debut and being the only product in the domestic market.

This year, the Ilaprazole enteric-coated tablets submitted by Shijiazhuang Pharmaceutical Group were approved for market release, marking the first domestic generic version and breaking Lizhu Group's nearly 20-year monopoly.

In the domestic generic drug landscape, PPIs have long dominated the acid suppression market. Currently, available drugs include omeprazole, Ilaprazole, pantoprazole, Ilaprazole, rabeprazole, and lansoprazole. Due to the large patient population, domestic pharmaceutical companies are actively entering the market. Public data shows that the patents for Ilaprazole compounds and enteric-coated tablets have expired, while other products, such as Ilaprazole injections, will expire in 2036, and the microtablet patent has been authorized until 2040.

In June 2022, Lizhu's Ilaprazole enteric-coated tablets were designated as a reference preparation, officially initiating competition in the generic drug market. Currently, besides Shijiazhuang Zhongnuo Pharmaceutical, which has secured the first domestic generic version, three other companies, including Chongqing Shenghuaxi Pharmaceutical, have submitted market applications, and 17 other companies, including Hunan Warner Pharmaceutical, Chenxin Pharmaceutical, and Shandong Langnuo Pharmaceutical, have registered for bioequivalence studies of Ilaprazole enteric-coated tablets.

It is reported that the domestic Ilaprazole enteric-coated tablet market has been monopolized by Lizhu Group under the brand name Yilian, which has been included in the latest national medical insurance catalog. Currently, the insurance restrictions apply to second-line medications for patients diagnosed with duodenal ulcers and gastroesophageal reflux disease. Ilaprazole enteric-coated tablets are a potent acid suppressant primarily used for treating peptic ulcers and gastroesophageal reflux disease caused by excessive gastric acid. According to the Moshan Pharmaceutical Database, the sales of Ilaprazole enteric-coated tablets in the national hospital market exceeded 1.3 billion yuan in 2023.

Development Prospects

Since its launch, Ilaprazole has seen rapid sales growth in public medical institutions in China, with even more pronounced growth after entering the medical insurance system. This product surpassed 1 billion yuan in 2019 and peaked at 3.5 billion yuan in 2021. In the first half of 2023, Ilaprazole became the second most popular drug in the market for treating diseases related to gastric acid secretion.

With national price negotiations leading to a decline in Ilaprazole injection sales, a recovery is anticipated. In 2022, domestic Ilaprazole sales reached 603 million yuan, with Ilaprazole injections accounting for 62.56% of total sales. Although Ilaprazole sales have declined year-on-year due to national price negotiations, as new indications for the product gradually gain traction and the impact of price negotiations becomes more apparent, it is expected that Ilaprazole will exchange price for volume, rapidly returning to high sales levels and achieving stable growth.

In summary, the Ilaprazole project demonstrates significant advantages in technological innovation, market potential, efficacy, and safety, and is supported by policies and professional guidelines. As a professional raw material pharmaceutical company, HRD pharm is committed to product innovation and process optimization to meet the ever-changing market demands and provide high-quality products to the market!