Claims for Patent: 8,709,475

Summary for Patent: 8,709,475

Title:	Stable pharmaceutical composition and methods of using same
Abstract:	The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
Inventor(s):	Manku; Mehar (Birmingham, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Assignee:	Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	13/897,120
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,709,475
Patent Claims:	1. A method of treating mixed dyslipidemia in a subject in need thereof comprising, administering to the subject daily a statin and 2500 mg to about 5000 mg of ethyl eicosapentaenoate to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 2. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 10% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 3. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 4. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 20% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 5. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 25% and LDL-C by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 6. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 7. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 8. The method of claim 1 wherein said administering step reduces fasting VLDL-C relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 9. The method of claim 1 wherein said administering step reduces fasting VLDL-C by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate. 10. The method of claim 1 wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin. 11. The method of claim 1 wherein the ethyl eicosapentaenoate is present in one or more dosage units. 12. The method of claim 11 wherein the dosage units comprise capsules.