Gilead Settles Patent Disputes To Block Generic Biktarvy Launch In U.S. Until April 2036

Author: Benzinga Newsdesk | October 06, 2025 08:24am

On October 6, 2025, Gilead Sciences, Inc., a Delaware corporation ("Gilead"), announced that it has entered into settlement agreements ("Agreements") to resolve the patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration to market generic versions of Biktarvy®. Under the Agreements, which are subject to standard acceleration provisions, no generic entry is expected prior to April 1, 2036 in the United States for Biktarvy tablets containing bictegravir (50 mg), emtricitabine (200 mg) and tenofovir alafenamide (25 mg).

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