Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2006-03-14
2006-03-14
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S480000
Reexamination Certificate
active
07011848
ABSTRACT:
An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day “nocturnally,” that is in the evening or at night.
REFERENCES:
patent: 5126145 (1992-06-01), Evenstad et al.
patent: 5268181 (1993-12-01), O'Neill et al.
patent: 6080428 (2000-06-01), Bova
patent: 6129930 (2000-10-01), Bova
Expert Report of Cheryl D. Blume, Ph.D. (Jan. 27, 2004) -Subject to Protective Order.
Expert Report of Dr. Sergio Fazio (Feb. 4, 2004) [Redacted Version] -Subject to Protective Order.
Rebuttal Expert Report of Dr. Sergio Fazio (Apr. 2, 2004) -Subject to Protective Order.
Expert Report of Dr. Sergio Fazio Regarding U.S. Pat. No. 6,676,967 (Aug. 17, 2004) -Subject to Protective Order.
Expert Report of Don W. Martens (Feb. 6, 2004) [Redacted Version] -Subject to Protective Order.
Expert Report of Don W. Martens Regarding U.S. Pat. No. 6,676,967 (Aug. 20, 2004) [Redacted Version] -Subject to Protective Order.
Expert Report of Dr. Joseph R. Robinson (Feb. 5, 2004) [Redacted Version] -Subject to Protective Order.
Expert Report of Dr. Joseph R. Robinson Regarding U.S. Pat. No. 6,676,967 (Aug. 18, 2004) -Subject to Protective Order.
Rebuttal Expert Report of Thomas S. Foster, Pharm.D. (Apr. 2, 2004) -Subject to Protective Order.
Rebuttal Expert Report of Thomas S. Foster, Pharm.D. Regarding The '967 Patent (Oct. 4, 2004) -Subject to Protective Order.
Rebuttal Expert Report of James W. McGinity, Ph.D (Apr. 2, 2004) -Subject to Protective Order.
Supplemental Rebuttal Expert Report of James W. McGinity, Ph.D. (Aug. 18, 2004) -Subject to Protective Order.
Rebuttal Expert Report of James W. McGinity, Ph.D. Regarding The '967 Patent (Sep. 30, 2004) -Subject to Protective Order.
Expert Report of Mark E. McGovern, M.D. (Feb. 6, 2004) -Subject to Protective Order.
Expert Report of Mark E. McGovern, M.D. (Aug. 20, 2004) -Subject to Protective Order.
Expert Report of Frank M. Sacks, M.D. (Apr. 2, 2004) -Subject to Protective Order.
Expert Report of Frank M. Sacks, M.D. (Aug. 20, 2004) -Subject to Protective Order.
Rebuttal Expert Report of Mary Ann Tucker, Esq. (Apr. 2, 2004) -Subject to Protective Order.
Rebuttal Expert Report of Mary Ann Tucker, Esq. Regarding The '967 Patent (Oct. 1, 2004) -Subject to Protective Order.
Carl J. Lavie, et al.,Marked Benefit with Sustained-Release Niacin Therapy in Patients with Alsolated @ Very Low Levels of High-Density Lipoprotein Cholesterol and Coronary Artery Disease, Am. J. Cardiol. 1992:69:1083-1085.
Excerpts from the 1993, 2000, and 2002 editions of the Physician's Desk Reference.
Niacin:Double-edged Sword for Lowering Cholesterol, Tufts University Diet & Nutritional Letter (Tufts Univ., Boston MA), Aug. 1994, vol. 12, issue 6.
Larsen, ML and Illingworth, DR,Drug Treatment of Dyslipoproteinemia, Med Clin N Am., 78:225-245 (1994).
Lavie, Letter to Editor, JAMA 1994; 272:513-515.
Keenan, Letter to Editor, JAMA 1994; 272:513-515.
Shields & Beckmann, Letter to Editor, JAMA 1994; 272:513-515.
Thomas N. Tozer, Clinical Pharmacokinetics Concepts and Applications (3d ed. 1995) at Chapter 9, p. 120.
Excerpts from the United States Pharmacopeia (1995).
Morgan & Capuzzi Abstract,Safe and Effective Treatment of Dyslipidemia by Niaspan, a New Sustained-Release Niacin, Clinical Pharmacology & Therapeutics (Feb. 1996).
Morgan & Capuzzi Article,Treatment Effect of Niaspan, a Controlled-release Niacin, in Patients With Hypercholesterolemia: A Placebo-controlled Trial, J. Cardiovasc. Pharmacol. Therapeut. 1(3):195-202 (Jul. 1996).
Capuzzi DM, et al.,Efficacy and Safety of An Extended-Release Niacin (Niaspan): A Long-Term Study, Am J Cardiol. 1998;82:74U-81U.
Guyton JR,Advances in Dyslipidemia: Discussion Session II, Am J Cardiol, 1998: 82(12A): 85U-86U.
Knopp RH, et al.,Equivalent Efficacy of a Time-Release Form of Niacin (Niaspan) Given Once-a-Night Versus Plain Niacin in the Management of Hyperlipidemia, Metabolism 47:1097-1104 (1998).
American Diabetes Association:Management of Dyslipidemia in Adults with Diabetes, Diabetes Care 21:179-182, 1998.
Elam MB, et al.,Effect of Niacin on Lipid and Lipoprotein Levels and Glycemic Control in Patients With Diabetes and Peripheral Arterial Disease, JAMA: 2000; 284:1263-1270.
Kesala R, et al.,Niacin (N) vs. Niaspan (NS) Treatment of the Atherogenic Lipid Profile (ALP; Small, Dense LDL, HDL2, HDLc and Triglycerides) and Lp(a) in Diabetic Patients (DP), Diabetes 49 (suppl. 1): A268 at 1114-P (Jun. 2000).
2001 NCEP Report at VI-11, Table VI.2-3.
Wang, W. et al.,Effect of Nicotinic Acid Administration on Hepatic Very Low Density Lipoprotein-Triglyceride Production, Am J Physiol Endocrinol Metab., 280:E540-E547 (2001).
Smith SC, et al.,AHA/ACC Guidelines for Preventing Heart Attack and Death in Patients with Atherosclerotic Cardiovascular Disease: 2001 Update. AHA/ACC Scientific Statement, 1577-79.
Tavintharan S and Kashyap M,The Benefits of Niacin in Atherosclerosis, Curr Athero. Reports 2001; 3:74-82.
Meadows M.,Serious Liver Injury: Leading Reason for Drug Removals, Restrictions, FDA Consumer Magazione, May-Jun. 2001;http://www.fda.gov/fdac/features/2001/301-liver.html.
Grundy SM, et al.,Efficacy, Safety, and Tolerability of Once-Daily Niacin for the Treatment of Dyslipidemia Associated with Type 2 Diabetes. Arch Intern Med. 2002; 162:1568-1576.
American Diabetes Association:Management of Dyslipidemia in Adults with Diabetes, Diabetes Care 25:S74-S77, 2002.
Pan J, et al.,Niacin Treatment of the Atherogenic Lipid Profile and Lp(a) in Diabetes, Diabetes, Obesity and Metabolism 4:255-261 (2002).
Pan J, et al,Extended-Release Niacin Treatment of the Atherogenic Lipid Profile and Lipoprotein(a) in Diabetes, Metabolism 51:1120-1127 (2002).
Meyers CD, et al.,Varying Cost and Free Nicotinic Acid Content in Over-the Counter Niacin Preparations far Dyslipidemia, Ann Intern Med. 2003; 139:996-1002.
CDER Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -General Considerations (Mar. 2003).
American Diabetes Association:Dyslipidemia Management in Adults with Diabetes, Diabetes Care 27:S68-S71, 2004.
Joynes Robert M.
KOS Pharmaceuticals, Inc.
Messick, Esq. Karen J.
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