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Gilead settles patent litigations with Biktarvy ANDA filerers

In a regulatory filing, Gilead (GILD) Sciences disclosed that on October 6, Gilead announced that it has entered into settlement 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, the filing stated.

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