China's First Generic Dolutegravir (DTG) Launches Online Following Patent Expiry

April 30,Tellingwe® Dolutegravir Sodium Tablets by Qilu Pharmaceutical Co., Ltd. Launched on AliHealth. This product is the first one approved for marketing in China.Dolutegravir Sodium Tablets Generic Drug, used in combination with other antiretroviral drugs for the treatment of HIV infection in adults and children aged 12 years and older.

Dolutegravir Sodium (Dolutegravir, DTG) belongs to the second-generation HIV integrase inhibitors (INSTI), jointly developed by ViiV Healthcare under GlaxoSmithKline (GSK) and Shionogi & Co., Ltd. of Japan. In August 2013, Dolutegravir Sodium Tablets were first approved for marketing in the United States under the brand name Tivicay. In December 2015, it officially entered the Chinese market.

The mechanism of action of Dolutegravir Sodium isBy blocking the integration of viral DNA into the genetic material of human immune cells to inhibit HIV replication. It has been jointly recommended by the World Health Organization (WHO), China, and relevant treatment guidelines in the United States asFirst-line Preferred Medication, is one of the core drugs in the current antiretroviral therapy (ART) regimen.

The original research drug Tivicay® has shown strong performance in the global market, reaching a sales peak of $22 billion in 2018. However, in the Chinese market, the total sales at hospital terminals in 2022 were only 20 million yuan, which is disproportionate to the number of HIV infections and the market size in China. The core reasons are the high price and insufficient accessibility.

In April 2023, the Center for Drug Evaluation of the National Medical Products Administration accepted the Category 4 generic drug marketing application for Dolutegravir Sodium Tablets submitted by Qilu Pharmaceutical. On September 8, 2023, an announcement on the official website of the National Medical Products Administration revealed that Qilu Pharmaceutical's Dolutegravir Sodium Tablets had been approved for marketing, becoming the first domestically produced generic version of Dolutegravir Sodium Tablets to be approved in China.

But there is a key patent issue here. The compound patent for Dolutegravir Sodium Tablets in China will expire on April 28, 2026. The patent declaration registered by Qilu Pharmaceutical at the time of approval shows that the compound patent falls under Category 3 declaration, and the drug composition patent falls under Category 2 declaration. This means that Qilu Pharmaceutical will only be able to officially sell its generic version after the compound patent expires.

On April 28, 2026, the patent will expire. On April 30, 2026, Telling® Dolutegravir Sodium Tablets will be launched for the first time on AliHealth. From approval to the first launch, nearly two and a half years have passed, which is extremely rare in the field of generic drugs—reflecting both the robust barrier of the original drug's patent and Qilu Pharmaceutical’s patience and precision in its patent strategy.

Choosing AliHealth as the launch channel was a carefully designed decision. HIV patients have extremely high requirements for privacy protection, and online channels can provide a more private medication purchasing experience. At the same time, as the "launch platform for novel specialty drugs," AliHealth, relying on its nationwide delivery network and online pharmaceutical service team, can provide full-process support for patients with chronic conditions like HIV and infectious diseases, ranging from online consultation to long-term medication management.

As the first domestically produced generic drug in China, Telinqi® will rapidly gain market share after the patent expiration. Drawing from experiences in other fields,First generic drugs typically capture over 50% of the generic drug market within 6-12 months after patent expiration.In the ongoing promotion of centralized drug procurement and medical insurance negotiations, domestically produced generic drugs have a natural advantage in terms of pricing. As older regimens like "Tilaiyi" are gradually replaced, new regimens centered around INSTI will rapidly gain popularity. Qilu Pharmaceutical, as the first Chinese manufacturer of INSTI generics, will fully benefit from this trend.

Through the strategic cooperation with AliHealth, Qilu Pharmaceutical has established a first-mover advantage in the online retail sector of HIV drugs. The demand for privacy protection among HIV patients gives online channels unique value. According to reports from Xinhua News Agency, as of now, Qilu Pharmaceutical has successfully obtained approval for nine anti-HIV drugs, ranging from single agents to combination therapies, from NRTIs to INSTIs, covering multiple targets and dosage forms, forming a relatively complete supply capability for anti-HIV treatment solutions.

But innovative drug companies like Adie Pharmaceutical are quickly catching up. Adie Pharmaceutical's ACC017 (a novel integrase inhibitor) has entered Phase III clinical trials, and ADC118 (a triple combination of ACC017/FTC/TAF) has been approved for clinical trials. If Adie Pharmaceutical’s innovative drugs successfully reach the market, they will create differentiated competition for Qilu Pharmaceutical's generic drugs.

All in all, this is a milestone, but more importantly, a starting point.

Reference Instructions：The information in this article is mainly derived from publicly available news reports, corporate announcements, industry research reports, and academic literature. Some judgments about future trends are speculations based on existing information and are for reference only.