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Profile for Tradename: LOVAZA

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Lovaza is a drug marketed by Smithkline Beecham and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for Tradename: LOVAZA

Suppliers: see list5

Pharmacology for Tradename: LOVAZA

Clinical Trials for: LOVAZA

Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Status: Recruiting Condition: Non-Alcoholic Fatty Liver Disease

Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
Status: Completed Condition: Hypertriglyceridemia

Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Status: Withdrawn Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status: Completed Condition: Hypertriglyceridemia

Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Status: Completed Condition: Hypertriglyceridemia

Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
Status: Terminated Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Status: Completed Condition: Hypertriglyceridemia

Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery
Status: Active, not recruiting Condition: Mitral Valve Regurgitation; Left Atrium Dilatation and Hypertrophy; Mitochondrial Dysfunction in the Heart; Cardiomyocyte Apoptosis; Cardiac Inflammation

Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
Status: Not yet recruiting Condition: Coronary Artery Disease

An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Status: Completed Condition: Hypertriglyceridemia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham
omega-3-acid ethyl esters
CAPSULE;ORAL021654Nov 10, 2004RXYes5,656,667<disabled>YY<disabled>
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Paragraph IV activity for: LOVAZA

Drugname Dosage Strength RLD Submissiondate
omega-3-acid ethyl estersCapsules1 gLovaza11/10/2008
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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