Gilead settles patent disputes over Biktarvy with generic drugmakers

Gilead Sciences Inc. (NASDAQ: GILD) announced it reached settlement agreements with three generic drug manufacturers to resolve patent litigation over Biktarvy, the company's HIV treatment medication.

The settlements involve Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd., which had filed abbreviated new drug applications with the U.S. Food and Drug Administration to produce generic versions of Biktarvy tablets.

Under the agreements announced October 6, no generic entry is expected before April 1, 2036 in the United States for Biktarvy tablets containing the specific combination of bictegravir (50 mg), emtricitabine (200 mg) and tenofovir alafenamide (25 mg).

The settlements include standard acceleration provisions, though Gilead did not specify the terms of these clauses in its announcement.

Biktarvy is used as a treatment for HIV infection. The settlement agreements resolve ongoing patent disputes that arose when the generic manufacturers sought regulatory approval to market competing versions of the medication.

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