Innovator Gilead Sciences confirmed (in a press release Here ) the receipt of a Paragraph IV Certification Notice Letter from generic player Teva Pharma on Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg (Atripla). The antiviral combination is currently sold in the United States through a joint venture between Bristol-Myers Squibb (BMS) and Gilead.
In the Notice Letter, Teva alleges that following two Orange Book listed patents associated with Emtricitabine are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission:
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
Earlier, Teva challenged the validity of these same two Emtricitabine patents with an ANDA filing for Truvada® (Emtricitabine and Tenofovir disoproxil fumarate) as reported by us Here. Subsequently, Innovator Gilead sued Teva in District Court in New York.
Earlier news of IPPharmadoc on this product Here
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