Singapore, Dec 15, 2008: Gilead Sciences has filed a lawsuit in US District Court in New York against Teva Pharmaceuticals USA and Teva Pharmaceutical Industries for infringement of US Patent Numbers 6,642,245 and 6,703,396.
Both patents are associated with emtricitabine, a component of Truvada (emtricitabine and tenofovir disoproxil fumarate), and are licensed exclusively to Gilead Sciences by Emory University. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
The lawsuit is based on an Abbreviated New Drug Application filed by Teva Pharmaceuticals USA which seeks approval to manufacture and market a generic version of Truvada before the expiration of both emtricitabine patents.
Truvada is currently protected by 10 patents that are listed in the FDA's Approved Drugs Products List, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed.
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