Innovator Gilead Sciences announced (in a press release Here) the receipt of a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals on its popular antiviral (HIV) combination . Generic player Teva submitted an Abbreviated New Drug Application (ANDA) to the USFDA requesting permission to manufacture and market a generic version of Truvada(R) (Emtricitabine and Tenofovir disoproxil fumarate; 200 mg +300 mg).
In the Notice Letter, Teva alleges that following two patents associated with Emtricitabine:
US6642245 (Expiry: May 4, 2021): which covers A method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): The (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Patented 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 described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Truvada is currently protected by 10 patents, which 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. USFDA approved this combination on Aug 2, 2004.
In the Notice Letter, Teva alleges that following two patents associated with Emtricitabine:
US6642245 (Expiry: May 4, 2021): which covers A method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): The (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Patented 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 described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Truvada is currently protected by 10 patents, which 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. USFDA approved this combination on Aug 2, 2004.
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