Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: LOVAZA

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

This drug has thirty-four patent family members in twenty-three countries.

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

Summary for Tradename: LOVAZA

Patents:1
Applicants:1
NDAs:1
Suppliers: see list6

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Status: Withdrawn Condition: Hypertriglyceridemia

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 Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
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

Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status: Completed Condition: Hypertriglyceridemia

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

A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD)
Status: Not yet recruiting Condition: Sickle Cell Disease; HEMOGLOBIN SS; Hemoglobin S Beta-0 Thalassemia; Inflammation; Quality of Life

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004RXYes5,656,667<disabled>YY<disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: LOVAZA

Drugname Dosage Strength RLD Submissiondate
omega-3-acid ethyl estersCapsules1 gLovaza11/10/2008

Non-Orange Book Patents for Tradename: LOVAZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications. They represent opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,698,594 Treatment and prevention of risk factors for cardiovascular diseases<disabled in preview>
5,502,077 Fatty acid composition<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: LOVAZA

Country Document Number Publication Date
Spain2018384Apr 01, 1991
Finland893805Feb 12, 1990
Japan2810916Oct 15, 1998
Luxembourg87570Jan 08, 1990
Sweden504742Apr 14, 1997
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn
`abc