Gilead Resolves Patent Litigations for HIV Treatment Biktarvy

Core Insights - Gilead Sciences, Inc. has reached settlement agreements with generic manufacturers to resolve patent litigations regarding its HIV treatment Biktarvy, which generated $6.7 billion in sales in the first half of 2025 [1][4][7] - The company's shares have increased by 25.6% year to date, outperforming the industry growth of 10.1% [2] Patent Settlements - Gilead has settled with Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd., preventing generic versions of Biktarvy from entering the U.S. market before April 1, 2036 [4][5][7] - These agreements provide nearly a decade of patent protection for Biktarvy, which holds over 51% of the U.S. HIV treatment market [5][7] HIV Portfolio Growth - Gilead's HIV portfolio has been bolstered by the FDA approval of lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 capsid inhibitor for prevention [6][8] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue growth, driven by strong performances from Biktarvy and Descovy [8] Competitive Landscape - The European Commission has granted marketing authorization for lenacapavir under the brand name Yeytuo, enhancing Gilead's competitive position [9] - Gilead's innovation efforts are crucial for maintaining growth amid competition from GSK, which has strong demand for its HIV products [9] Collaborations and Future Developments - Gilead is collaborating with Merck to evaluate a combination treatment for HIV, with a phase III update expected in 2026 [10] - Merck has also submitted a new drug application for a once-daily oral regimen for HIV treatment, with a target action date set for April 28, 2026 [11]