Thanks to new settlement agreements with three generic drug makers, Gilead Sciences has extended the expected life span of its flagship HIV treatment Biktarvy by as many years.
Gilead has struck accords with Lupin, Cipla and Laurus Labs to delay the entry of any Biktarvy copycats in the U.S. until April 1, 2036. Gilead inked the settlements after each of the three generic drug makers filed applications for generic Biktarvy with the FDA, according to an Oct. 6 securities filing (PDF).
Gilead had previously estimated that Biktarvy’s U.S. market exclusivity would run out (PDF) in 2033, according to the company’s latest annual report.
First approved in early 2018 to treat HIV-1 infection, Biktarvy has expanded its U.S. label multiple times and currently holds the title of Gilead’s top-selling medicine.
For all of 2024, Biktarvy generated total sales of $13.42 billion, growing 13% over the sum it brought home in 2023. A whopping $10.9 billion of those sales came in the U.S., according to Gilead’s 2024 annual report.
The settlement announcement marks a “significant positive" for Gilead, analysts at Leerink Partners wrote in a note to clients Monday.
“Biktarvy sales continue to grow given its strong efficacy and safety profile and single-tablet regimen, and we see potential for market share to expand well beyond Biktarvy’s current >50%,” the Leerink team said.
As Biktarvy inches closer to the patent cliff, Gilead has been working to safeguard its pole position in the HIV market through the next decade.
Central to that plan is lenacapavir, first approved as the multidrug-resistant HIV treatment Sunlenca and more recently cleared by the FDA as the twice-yearly preexposure prophylaxis (PrEP) med Yeztugo.
Gilead has hailed Yeztugo as a game changer for PrEP users, though analysts have stressed that the company will have its work cut out to further unlock the market, especially as it seeks to establish a foothold for the drug overseas.
The company has been working to set up access deals to provide low-cost lenacapavir around the globe, and recently, the U.S. Centers for Disease Control and Prevention issued a resounding endorsement of Yeztugo for PrEP.
Gilead’s Biktarvy settlements come a little less than a month after AbbVie charted a similar maneuver around its immunology med Rinvoq, which the company is leveraging—alongside its sister medicine Skyrizi—to sweep up sales once dominated by Humira.
In early September, the Chicago drugmaker reached settlements with Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceuticals, preventing the entry of Rinvoq generics in the U.S. until April 2037.