Gilead Sciences Inc. (NASDAQ:GILD) shares climbed 4.5% on Monday after the company announced it had resolved patent litigation with several generic drugmakers involving its blockbuster HIV therapy Biktarvy.
The biopharmaceutical firm said it has reached settlement agreements with Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd., which had submitted abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA) seeking approval to market generic versions of Biktarvy.
According to a recent SEC filing, the settlements guarantee that no generic versions of Biktarvy will be launched in the U.S. before April 1, 2036, effectively extending Gilead’s market exclusivity for one of its most important products.
Biktarvy is a once-daily combination tablet containing bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), providing a complete HIV treatment regimen in a single pill. Gilead noted that the agreements remain subject to standard acceleration provisions.
The settlement removes a key legal overhang for Gilead and potentially secures more than a decade of additional exclusivity for Biktarvy — a drug that has been a significant revenue contributor in recent years. The resolution also reinforces Gilead’s intellectual property protection while clarifying the timeline for future generic competition in the U.S. market.
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