Shandong Langnuo Pharma Enters the $570M Etoricoxib Market with Approved Generic COX-2 Inhibitor

Recently, the official website of the National Medical Products Administration (NMPA) indicated that Etoricoxib Tablets from Shandong Langnuo Pharmaceutical Co., Ltd. have been approved under the Class 4 generic drug registration pathway and are deemed to have passed the consistency evaluation, making it the fourth company in China to receive approval for this product. According to Menet data, in 2020, the total sales of Etoricoxib Tablets through public medical institutions and urban retail pharmacies in China exceeded RMB 400 million, with MSD accounting for over 90% of the market share. Currently, there are five manufacturers for this product, including MSD, Qilu Pharmaceutical, and Chengdu Yuont Bio-pharma. In addition, the marketing applications submitted by Shanghai Haini Pharmaceutical of Yangtze River Pharmaceutical Group, Kunming Jida Pharmaceutical, and Chengdu Baiyu Pharmaceutical are currently under review and approval.

Etoricoxib Tablets, developed by MSD, is a latest-generation selective cyclooxygenase-2 (COX-2) inhibitor with anti-inflammatory, analgesic, and antipyretic effects. It is associated with a lower incidence of gastrointestinal adverse reactions and is indicated for the treatment of signs and symptoms of acute and chronic osteoarthritis, among other conditions.

Sales of Etoricoxib Tablets in China's Urban Physical Pharmacy Retail Channels in Recent Years (Unit: 10,000 RMB)

Source: MENET Competitive Landscape of China's Urban Physical Pharmacy Terminal

Data from Menet shows that in 2020, the combined sales of etoricoxib tablets in China's public medical institutions (including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) and urban physical pharmacy terminals exceeded RMB 400 million, with MSD accounting for over 90% of the market share. Notably, sales of etoricoxib tablets in China's urban physical pharmacy terminals have experienced rapid growth in recent years, with a growth rate exceeding 8% in 2020.

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Source: Menet One-Click Search

Etoricoxib Tablets are manufactured by five companies, including MSD, Qilu Pharmaceutical, and Chengdu Yuandong Biopharmaceutical. Among them, four domestic enterprises, including Qilu Pharmaceutical, Chengdu Yuandong Biopharmaceutical, and Beijing Tide Pharmaceutical, obtained marketing approval through Class 4 generic applications, which are deemed to have passed the consistency evaluation.

Source: MENET MED2.0 China Drug Evaluation Database

Currently, marketing authorization applications for this product submitted by three other companies—Shanghai Haini Pharmaceutical Co., Ltd. (Yangtze River Pharmaceutical Group), Kunming Jida Pharmaceutical Co., Ltd., and Chengdu Baiyu Pharmaceutical Co., Ltd.—are also under regulatory review and approval.

Source: Official website of the National Medical Products Administration, MENET database