Norway-based biotechnology company Pronova BioPharma has reported that Pronova BioPharma Norge AS has filed a lawsuit against Teva Pharmaceuticals USA and Teva Pharmaceutical Industries Ltd in the US District Court of Delaware asserting infringement of the company's US patents relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters.
These patents are listed in the FDA's Orange Book and expire in 2013 and 2017, respectively.
The lawsuit is in response to Teva USA's Paragraph IV Certification notice to Pronova BioPharma advising that Teva USA has submitted an abbreviated new drug application to the FDA seeking approval to engage in the commercial manufacture, use, or sale of generic versions of Pronova BioPharma's omega-3-acid ethyl esters capsules which are marketed in the US as Lovaza.
Omacor/Lovaza is reported to be the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia, a form of dyslipidemia.
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