Innovator Pronova BioPharma announced (in a press release Here) that Pronova and its U.S. marketing partner GlaxoSmithKline have received a Paragraph IV Notice Letter dated March 9 2009 from Teva advising that Teva has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market a generic version of Omega-3-acid Ethyl Esters 1 g capsules (Lovaza).
Following patents are listed in Orange Book for Omega-3-acid Ethyl Esters (Lovaza) 1 g capsules:
US5502077 (Expiry: Mar 26, 2013): Which covers a method for the treatment or prophylaxis of hypertriglyceridemia in a human patient, which comprises orally administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids
US5656667 (Expiry: Aug 27, 2018): Which covers a method for elevating the HDL cholesterol level in the serum of a human patient, which comprises administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids.
US5698594 (Expiry: Aug 4, 2009): Which covers a method for the treatment or prophylaxis of hypertension in an adult human patient, which comprises administering to the patient, on a daily basis, an effective amount of a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and of which at least 1% by weight of the mixture of fatty acids is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid.
Teva's notice letter states that its ANDA contains a Paragraph IV Certification alleging that the '077 and '667 patents are not valid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of Teva's product.
As per press release, innovator Pronova has full confidence in its intellectual property portfolio protecting Lovaza(TM) and will vigorously defend and enforce its patents.
LOVAZA (Omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce very high (≥500 mg/dL) triglyceride (TG) levels in adult patients, the approved formulation also contains fish oils. USFDA approved omega-3-acid ethyl esters (Lovaza) on Nov 10, 2004.
Following patents are listed in Orange Book for Omega-3-acid Ethyl Esters (Lovaza) 1 g capsules:
US5502077 (Expiry: Mar 26, 2013): Which covers a method for the treatment or prophylaxis of hypertriglyceridemia in a human patient, which comprises orally administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids
US5656667 (Expiry: Aug 27, 2018): Which covers a method for elevating the HDL cholesterol level in the serum of a human patient, which comprises administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids.
US5698594 (Expiry: Aug 4, 2009): Which covers a method for the treatment or prophylaxis of hypertension in an adult human patient, which comprises administering to the patient, on a daily basis, an effective amount of a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and of which at least 1% by weight of the mixture of fatty acids is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid.
Teva's notice letter states that its ANDA contains a Paragraph IV Certification alleging that the '077 and '667 patents are not valid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of Teva's product.
As per press release, innovator Pronova has full confidence in its intellectual property portfolio protecting Lovaza(TM) and will vigorously defend and enforce its patents.
LOVAZA (Omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce very high (≥500 mg/dL) triglyceride (TG) levels in adult patients, the approved formulation also contains fish oils. USFDA approved omega-3-acid ethyl esters (Lovaza) on Nov 10, 2004.
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