Thursday, 26 March 2009

Omega-3-acid Ethyl Esters (Lovaza) 1 g capsules: Pronova received Paragraph IV notice letter from Apotex

Innovator Pronova BioPharma announced (in a press release) that Pronova and its U.S. marketing partner GlaxoSmithKline have received a Paragraph IV Notice in March, 2009 from Canadian Pharma giant Apotex advising that Apotex has submitted an Abbreviated New Drug Application (ANDA) to the USFDA for approval to market a generic version of Omega-3-acid Ethyl Esters 1 g capsules (Lovaza).

Apotex's notice letter states that its ANDA contains a Paragraph IV Certification alleging that the US5502077 (Expiry: Mar 26, 2013) and US5656667 (Expiry: Aug 27, 2018) patents are not valid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of Par's product.

Also, Teva and Par has filed ANDA with Paragraph IV certification against this product as reported earlier by IP Pharma Doc Here and Here

Posted by ADKS at 9:52 am

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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