Qilu Pharma Set to Capture $1.4B Truvada Market as Generic Nears Approval

Recently, Qilu Pharmaceutical’s application for marketing approval of its generic emtricitabine/tenofovir disoproxil fumarate tablets, filed under Category 4, has entered the administrative review stage, with approval expected in the near future. Data from Menet shows that global sales of Gilead Sciences’ emtricitabine/tenofovir disoproxil fumarate tablets have been declining in recent years, dropping from $3.566 billion in 2016 to $2.813 billion in 2019, and then halving to $1.448 billion in 2020.

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are a combination formulation of emtricitabine and tenofovir disoproxil fumarate, developed by Gilead Sciences under the brand name Truvada, which was launched in the United States in 2004.

Data from Menet shows that in recent years, the global sales of Gilead’s emtricitabine/tenofovir have gradually declined, dropping from $3.566 billion in 2016 to $2.813 billion in 2019, and then halving to $1.448 billion in 2020. In China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—the sales of emtricitabine/tenofovir tablets have grown rapidly. Although the sales volume was less than RMB 50 million in 2019, it represented a year-on-year increase of 86.59%. In the first half of 2020, the year-on-year growth exceeded 15%.

Source: Menet One-Click Search

Currently, there are four manufacturers of emtricitabine/tenofovir disoproxil fumarate tablets in the Chinese market. Among them, three domestic companies—Chia Tai Tianqing Pharmaceutical Group, Anhui Beker Biopharmaceutical, and Haisco Pharmaceutical (Meishan)—have all been approved under Category 4 generic drug applications, which is considered equivalent to passing the consistency evaluation. In addition, Shanghai Desano’s marketing application for emtricitabine/tenofovir disoproxil fumarate tablets is under review and approval, while Qilu Pharmaceutical’s registration status for this product has been updated to “under approval.” Upon approval, Qilu Pharmaceutical will become the fourth domestic manufacturer.

Source: Official Website of the National Medical Products Administration, Menet Database