Gilead Sciences Inc.
10/06/2025 | Press release | Distributed by Public on 10/06/2025 06:17
Regulation FD Disclosure (Form 8-K)
Item 7.01 Regulation FD Disclosure.
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).
This filing includes forward-looking statements that are subject to the safe harbors provided under the Securities Act of 1933, as amended (the "Securities Act"), and the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statement other than statements of historical fact are forward-looking statements, including statements regarding patent protection and estimated loss of exclusivity for our products, and involve risks and uncertainties that may cause actual results or outcomes to differ materially. These risks and uncertainties include challenges to intellectual property, adverse litigation or government action, changes to laws and regulations applicable to our industry, as well as other risks and uncertainties described in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission (the "SEC"). The forward-looking statements included in this filing are made only as of the date hereof unless otherwise specified. Except as required under federal securities laws and the rules and regulations of the SEC, Gilead does not undertake, and specifically declines, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after this filing.
The information in Item 7.01 shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing.
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