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Gilead Sciences, Inc.
Gilead Sciences Announces Notification of ANDA Filing for Truvada
December 13th, 2008
Gilead Sciences, Inc. (Nasdaq:GILD) announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate). In the Notice Letter, Teva alleges that two of the patents associated with emtricitabine - U.S. Patent Numbers 6,642,245 and 6,703,396 - owned by Emory University and licensed exclusively to Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product...
Source: Law & Health Weekly (2008-12-13)
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