Qilu Pharmaceutical's First Generic Dolutegravir Sodium Tablets Approved for HIV Treatment

On September 8, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical's Dolutegravir Sodium Tablets have been approved for marketing in China. The drug is indicated for the treatment of AIDS (HIV infection) and is the first generic Dolutegravir Sodium Tablets to be approved for sale in China.

Dolutegravir (brand name: Tivicay), developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline (GSK), is an HIV integrase inhibitor that blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells.

Dolutegravir Sodium Tablets were first launched in the United States in August 2013, followed by the European Union in January 2014, and entered the Chinese market in December 2015 for the treatment of adult and HIV patients aged 12 years and above. Dolutegravir Sodium Dispersible Tablets were launched in the United States in November 2020 and in the European Union in January 2021 for the treatment of pediatric HIV patients. In June 2023, Dolutegravir Sodium Dispersible Tablets were also approved for marketing in China. This dispersible tablet dissolves quickly and evenly in water and can be used for pediatric HIV patients. Compared with conventional tablets, dispersible tablets have the advantages of convenient administration, rapid absorption, high bioavailability, and minimal adverse reactions.

In terms of market performance, the sales revenue of Dolutegravir in 2022 was 1.381 billion pounds. The core patent expiration time for Dolutegravir is 2028.

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