Dolutegravir Sodium Tablets” from Aidea Pharma has been approved in China
On March 15, 2026, Aidea Pharma announced that its Dolutegravir Sodium Tablets (brand name: Tivicay) had been approved for marketing in China. The product was registered and applied for as a Class 4 chemical drug, and its approval was deemed to have passed the generic drug quality and efficacy consistency evaluation. Dolutegravir Sodium Tablets are an HIV-1 integrase strand transfer inhibitor (INSTI) and are currently a core first-line treatment drug in the global HIV infection treatment field. The approved indication for Aidea Pharma’s Dolutegravir Sodium Tablets is for use in combination with other antiretroviral drugs to treat adult and pediatric patients aged 12 and above with human immunodeficiency virus (HIV) infection.
The original drug of this product was developed by GlaxoSmithKline plc (GSK)/ViiV Healthcare. It was approved for marketing in the United States in August 2013 and entered the Chinese market in December 2015. The original drug of this product has been unanimously recommended as one of the preferred first-line treatment options for adults and adolescents with HIV infection by mainstream diagnostic and treatment guidelines at home and abroad, including the Chinese <Guidelines for Diagnosis> and Treatment of AIDS, the US DHHS Guidelines, and the European EACS Guidelines.
It is understood that Aidea Pharma is a leading enterprise in the domestic HIV prevention and treatment field. The company has previously launched Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets (Fubangde). The approval of this new product will further enrich the company’s anti-AIDS drug portfolio, complementing the already marketed non-nucleoside reverse transcriptase inhibitors Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, improving the clinical treatment plan layout, and contributing to China’s AIDS prevention and control efforts.
Currently, The originator dolutegravir sodium product has two patents listed on the China National Drug Patent Information Registration Platform. Among them, Patent 200680022891.4 remains valid based on the Decision of Examination on Request for Invalidation (No. 49121), but it will expire on April 28, 2026. The other patent 200980149697.6, remains valid based on the Decision of Examination on Request for Invalidation (No. 51358), but its Claims 1-10 do not cover originator dolutegravir sodium product. From this, it can be inferred that the patent protection for the original research drug of DTG will expire entirely on April 28, 2026, and a batch of generic drug companies will likely initiate generic production at that time.
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