US Patent No: 6,746,691
Number of patents in Portfolio can not be more than 2000
Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
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Jun 8, 2004
Issued date -
Oct 31, 1997
filing date -
08/962,424
serial no -
In Force
status
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Abstract
Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, which are suitable for oral administration once per day as a single dose preferably administered during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg. The 375 mg, 500 mg and 750 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F.sub.2 of at least 44.
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First Claim
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International Classification(s)
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Cited Art
| Patent Info | (Count) | # Cites | Year |
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| 4,348,399 Antiatherosclerotic and hypolipidemic 4-(monoalkylamino)phenyl alkane, alkene and alkyne carbinols, aldehydes, carboxylic acids and derivatives | 20 | 1978 | |
| 4,230,878 Hypolipidemic and antiatherosclerotic 4-[(cyclopropyl alkyl)amino]benzoic acids and derivatives | 6 | 1978 | |
| 4,205,085 Hypolipidemic and antiatherosclerotic 4-(polyfluoroalkylamino)phenyl compounds | 10 | 1978 | |
| 4,211,783 Hypolipidemic and antiatherosclerotic novel 4-(aralkyl- and heteroarylalkylamino)phenyl compounds | 15 | 1978 | |
| 4,382,143 Hypolipidemic and antiatherosclerotic novel (monosubstituted-amino)heteroaryl carboxylic acids and analogs | 24 | 1979 | |
| 4,305,959 Hypolipidemic and antiatherosclerotic 4-(polyfluoro-alkylamino)phenyl compounds | 7 | 1979 | |
| 4,310,545 Hypolipidemic and antiatherosclerotic 4-(polyfluoroalkylamino) phenyl compounds | 12 | 1979 | |
| 4,318,914 Hypolipidemic and antiatherosclerotic 4-(polyfluoro-alkylamino)phenyl compounds | 7 | 1979 | |
| 4,485,105 Method of treating hyperlipidemia with 4-(monoalkylamino)benzoic acid amides | 25 | 1980 | |
| 4,440,940 Anti-atherosclerotic agents | 20 | 1981 | |
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| 4,795,644 Device for pH independent release of drugs through the Donnan-like influence of charged insoluble resins | 54 | 1987 | |
| 4,814,183 Device for the controlled release of drugs with Donnan-like modulation by charged insoluble resins | 42 | 1987 | |
| 4,997,658 Method for enhancing the lowering of plasma cholesterol levels | 12 | 1988 | |
| 5,049,696 Antihypercholesterolemic compounds | 8 | 1989 | |
| 5,009,895 Sustained release with high and low viscosity HPMC | 22 | 1990 | |
| 5,010,105 Antihypercholesterolemic compounds | 8 | 1990 | |
| 5,182,298 Cholesterol lowering agents | 16 | 1991 | |
| 5,262,435 Cholesterol lowering compounds | 16 | 1992 | |
| 5,258,401 Cholesterol lowering compounds | 10 | 1992 | |
| 5,256,689 Cholesterol lowering compounds | 12 | 1992 | |
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| 4,203,439 Osmotic system with volume amplifier for increasing amount of agent delivered therefrom | 97 | 1978 | |
| 4,256,108 Microporous-semipermeable laminated osmotic system | 324 | 1979 | |
| 4,326,525 Osmotic device that improves delivery properties of agent in situ | 95 | 1980 | |
| 4,576,604 Osmotic system with instant drug availability | 84 | 1983 | |
| 4,673,405 Osmotic system with instant drug availability | 44 | 1986 | |
| 4,871,548 Controlled release dosage form comprising different cellulose ethers | 64 | 1987 | |
| 4,851,232 Drug delivery system with means for obtaining desirable in vivo release rate pattern | 36 | 1987 | |
| 4,915,952 Composition comprising drug, HPC, HPMC and PEO | 14 | 1989 | |
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| 4,505,890 Controlled release formulation and method | 22 | 1983 | |
| 4,610,870 Controlled release formulation | 71 | 1984 | |
| 4,756,911 Controlled release formulation | 75 | 1986 | |
| 4,792,452 Controlled release formulation | 88 | 1987 | |
| 5,130,333 Method for treating type II diabetes employing a cholesterol lowering drug | 43 | 1990 | |
| 5,169,638 Buoyant controlled release powder formulation | 78 | 1991 | |
| 5,190,970 Method for preventing onset of or treating Type II diabetes employing a cholesterol lowering drug alone or in combination with an ace inhibitor | 34 | 1991 | |
| 5,260,305 Combination of pravastatin and nicotinic acid or related acid and method for lowering serum cholesterol using such combination | 28 | 1992 | |
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| 4,226,849 Sustained release therapeutic compositions | 74 | 1979 | |
| 4,357,469 Carrier base material for prolonged release therapeutic compositions | 38 | 1981 | |
| 4,369,172 Prolonged release therapeutic compositions based on hydroxypropylmethylcellulose | 212 | 1981 | |
| 4,389,393 Sustained release therapeutic compositions based on high molecular weight hydroxypropylmethylcellulose | 208 | 1982 | |
| 4,795,327 Controlled release solid drug dosage forms based on mixtures of water soluble nonionic cellulose ethers and anionic surfactants | 31 | 1984 | |
| 4,540,566 Prolonged release drug dosage forms based on modified low viscosity grade hydroxypropylmethylcellulose | 64 | 1984 | |
| 4,849,229 Controlled release solid drug dosage forms based on mixtures of water soluble nonionic cellulose ethers and anionic surfactants | 27 | 1988 | |
| 4,983,398 Sustained release drug dosage forms containing hydroxypropylmethylcellulose and alkali metal carboxylates | 23 | 1988 | |
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| 4,285,951 2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentyl ester of 3-pyridine carboxylic acid and use as an anti-atherosclerotic agent | 10 | 1979 | |
| 4,747,881 Ingestible aggregate and delivery system prepared therefrom | 104 | 1985 | |
| 4,814,354 Lipid regulating agents | 33 | 1986 | |
| 4,851,233 Sustained release formulations | 13 | 1986 | |
| 4,789,549 Sustained release dosage forms | 25 | 1987 | |
| 4,950,689 Pectin delivery system | 18 | 1987 | |
| 5,030,653 Antihyperlipidemic and antiatherosclerotic compounds and compositions | 15 | 1990 | |
| 5,167,964 Semi-enteric drug delivery systems and methods for preparing same | 65 | 1992 | |
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| 4,282,233 Antihistaminic 11-(4-piperidylidene)-5H-benzo-[5,6]-cyclohepta-[1,2-b]-pyridines | 100 | 1980 | |
| 4,695,591 Controlled release dosage forms comprising hydroxypropylmethylcellulose | 40 | 1985 | |
| 4,657,757 Controlled release dosage form comprising acetaminophen, pseudoephedrine sulfate and dexbrompheniramine maleate | 14 | 1985 | |
| 4,990,535 Pharmaceutical composition comprising loratadine, ibuprofen and pseudoephedrine | 51 | 1989 | |
| 5,100,675 Sustained release tablet comprising loratadine, ibuprofen and pseudoephedrine | 49 | 1990 | |
| 5,262,165 Transdermal nitroglycerin patch with penetration enhancers | 25 | 1992 | |
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| 4,940,588 Controlled release powder and process for its preparation | 129 | 1988 | |
| 4,952,402 Controlled release powder and process for its preparation | 157 | 1988 | |
| 5,015,479 Sustained release capsule or tablet formulation comprising a pharmaceutically acceptable dihydropyridine | 38 | 1988 | |
| 4,973,469 Drug delivery system | 54 | 1989 | |
| 5,128,142 Sustained release drug delivery system | 42 | 1989 | |
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| 4,678,516 Sustained release dosage form based on highly plasticized cellulose ether gels | 57 | 1984 | |
| 4,734,285 Sustained release compositions | 36 | 1985 | |
| 4,704,285 Sustained release compositions comprising hydroxypropyl cellulose ethers | 57 | 1985 | |
| 5,039,341 Binder composition comprises a blend of a high viscosity and low viscosity hydroxypropyl methylcellulose ether, and a tape joint composition containing such binder | 19 | 1989 | |
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| 4,375,468 Constant order release aspirin composition and method of treating arthritis | 32 | 1982 | |
| 4,461,759 Constant release rate solid oral dosage formulations of veropamil | 31 | 1983 | |
| 4,522,804 Constant release rate solid oral dosage formulations of propranolol | 13 | 1984 | |
| 4,525,345 Constant order release, solid dosage indomethacin formulation and method of treating arthritis and other inflammatory conditions | 25 | 1984 | |
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| 4,248,857 Sustained release pharmaceutical compositions | 43 | 1979 | |
| 4,309,404 Sustained release pharmaceutical compositions | 67 | 1981 | |
| 5,190,940 Cholesterol ester hydrolase inhibitors | 6 | 1991 | |
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| 4,803,081 New pharmaceutical preparations with extended release | 35 | 1987 | |
| 4,942,040 Pharmaceutical preparation and a process for its preparation | 37 | 1988 | |
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| 4,708,834 Preparation of gelatin-encapsulated controlled release composition | 70 | 1986 | |
| 4,795,642 Gelatin-encapsulated controlled-release composition | 55 | 1987 | |
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| 4,605,666 Process for preparing spray-dried powders containing a water-soluble vitamin and powders prepared thereby | 16 | 1984 | |
| 4,830,859 Process for lubricating water-soluble vitamin powders | 8 | 1987 | |
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| 4,367,217 Dipyricamole sustained release forms comprising lacquer-coated particles and the preparation thereof | 49 | 1980 | |
| 5,286,736 Pyridyl compounds and pharmaceutical compositions containing these compounds | 11 | 1993 | |
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| 4,812,316 Process for the preparation of stabilized isosorbide-5-mononitrate tablets, being also of sustained release, and formulations thus obtained | 12 | 1986 | |
| 5,047,248 Formulation for preparing sustained release drugs for oral administration | 27 | 1989 | |
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| 4,844,907 Pharmaceutical composition comprising analgesic and anti-inflammatory agent | 98 | 1986 | |
| 4,834,965 Controlled release pharmaceutical composition | 59 | 1987 | |
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| 4,428,951 Long acting pharmaceutical composition | 7 | 1982 | |
| 4,695,467 Sustained release tablet | 57 | 1985 | |
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| 5,023,245 Improved niacin formulation | 29 | 1989 | |
| 5,096,714 Prolonged release drug tablet formulations | 36 | 1989 | |
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| 4,792,554 Pyridine compounds, pharaceutical compositions, their use in allergy therapy | 9 | 1986 | |
| 4,935,246 Process for the coating of granules | 99 | 1988 | |
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| RE32581 Certain substituted phenyl esters of nicotinic acid, compositions and methods of using same for treatment of hyperlipidemia | 13 | 1984 | |
| 4,758,581 Pyridyl N-oxides | 6 | 1987 | |
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| 4,911,917 Cholesterol-lowering combination comopsitions of magnesium salt and niacin | 13 | 1988 | |
| 4,965,252 Cholesterol-lowering combination compositions of guar gum and niacin | 19 | 1988 | |
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| 4,261,970 Theophylline sustained release granule | 21 | 1980 | |
| 4,692,337 Sustained release pharmaceutical tablet of theophylline and production process thereof | 25 | 1984 | |
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| 5,034,528 Compositions for the control of hyperlipidemia | 7 | 1988 | |
| 4,946,963 Compounds for the control of hyperlipidemia using N-substituted isoxazolidine-3,5-diones | 6 | 1988 | |
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| 4,994,276 Directly compressible sustained release excipient | 69 | 1988 | |
| 5,169,639 Controlled release verapamil tablets | 33 | 1991 | |
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| 4,828,836 Controlled release pharmaceutical composition | 129 | 1987 | |
| 4,834,985 Controlled release pharmaceutical composition | 161 | 1987 | |
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| 4,539,198 Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range | 38 | 1983 | |
| 4,690,824 Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range | 16 | 1985 | |
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| 4,432,966 Compressed tablets for disintegration in the colon comprising an active ingredient containing nucleus coated with a first layer containing microcrystalline cellulose which is coated with an enteric organic polymer coating | 78 | 1982 | |
| 4,478,819 Novel oral preparations | 41 | 1983 | |
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| 5,169,640 Pharmaceutical compositions | 22 | 1989 | |
| 5,188,839 Pharmaceutical compositions of cimetidine | 20 | 1989 | |
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| 4,571,333 Controlled release naproxen and naproxen sodium tablets | 47 | 1983 | |
| 4,803,079 Controlled release naproxen and naproxen sodium tablets | 49 | 1985 | |
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| 5,126,145 Controlled release tablet containing water soluble medicament | 97 | 1990 | |
| 5,268,181 Method of using niacin to control nocturnal cholesterol synthesis | 18 | 1992 | |
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| 4,755,544 Sustained release preparation | 48 | 1986 | |
| 4,729,895 Composition for solid pharmaceutical preparations of active vitamins D.sub.3 | 24 | 1987 | |
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| 4,992,278 Therapeutic system for sparingly soluble active ingredients | 31 | 1989 | |
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| 4,888,178 Galenic formulations with programmed release containing naproxen | 25 | 1989 | |
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| 4,684,516 Sustained release tablets and method of making same | 43 | 1985 | |
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| 4,251,519 Process for the prevention and reduction of elevated blood cholesterol and triglycerides levels | 25 | 1979 | |
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| 4,925,905 Preparation of water-soluble copolymers based on monoethylenically unsaturated carboxylic acids | 10 | 1989 | |
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| 4,892,741 Press coated DHP tablets | 58 | 1988 | |
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| 4,749,575 Microencapsulated medicament in sweet matrix | 116 | 1986 | |
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| 4,361,546 Retard form of pharmaceuticals with insoluble porous diffusion coatings | 34 | 1981 | |
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| 4,547,359 Divisible pharmaceutical tablet with delayed active ingredient release | 16 | 1984 | |
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| 5,110,940 Antihypercholesterolemic tetrazole compounds | 6 | 1991 | |
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| 5,011,947 Antihypercholesterolemic alkylene compounds | 10 | 1990 | |
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| 5,213,808 Controlled release article with pulsatile release | 128 | 1990 | |
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| 4,568,547 Solid pharmaceutical compositions comprising MSM and their production | 26 | 1984 | |
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| 4,454,108 Prolonged-action multiple-layer tablets | 26 | 1982 | |
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| 4,353,887 Divisible tablet having controlled and delayed release of the active substance | 51 | 1980 | |
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| 4,457,907 Composition and method for protecting a therapeutic drug | 89 | 1982 | |
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| 4,283,382 Fluorescent labels comprising rare earth chelates | 59 | 1978 | |
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| 4,959,478 Method of producing-coarse crystalline nicotinic acid with a high degree of purity | 7 | 1989 | |
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| 5,133,974 Extended release pharmaceutical formulations | 202 | 1990 | |
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| 4,968,508 Sustained release matrix | 58 | 1989 | |
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| 4,362,711 Blood cholesterol level reducing agent and method | 23 | 1980 | |
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| 4,837,032 Theophylline sustained release tablet | 18 | 1986 | |
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| 5,002,774 Sustained release pharmaceutical tablet | 15 | 1989 | |
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| 5,211,958 Pharmaceutical composition and process for its preparation | 17 | 1992 | |
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| 5,278,067 Cyclic ketal derivatives | 6 | 1992 | |
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| 4,759,923 Process for lowering serum cholesterol using poly(diallylmethylamine) derivatives | 105 | 1987 | |
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| 4,695,910 Recording disc cartridge having an improved hub assembly | 21 | 1984 | |
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| 4,744,907 Blood cell separation | 7 | 1987 | |
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| 4,556,678 Sustained release propranolol tablet | 32 | 1982 | |
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| 4,308,251 Controlled release formulations of orally-active medicaments | 54 | 1980 | |
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| 4,603,142 Cholesterol lowering method of use | 45 | 1984 | |
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| 5,171,570 Substance having suppressing function for diseases relating to increase in cholesterol, and foods and drinks in which it is used | 15 | 1990 | |
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| 4,465,660 Sustained release tablet containing at least 95 percent theophylline | 22 | 1982 | |
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| 4,775,483 Method to reduce plasma cholesterol | 34 | 1986 | |
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| 5,314,697 Stable extended release oral dosage composition comprising loratadine and pseudoephedrine | 37 | 1992 | |
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| 4,777,042 Cholesterol level-lowering agents | 21 | 1987 | |
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| 4,713,245 Granule containing physiologically-active substance, method for preparing same and use thereof | 42 | 1985 | |
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| 4,279,898 In vivo inhibitors of cholesterol biosynthesis | 6 | 1980 | |
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| 4,472,436 Increasing HDL-cholesterol levels with phenylethylamine derivatives | 8 | 1982 | |
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| 4,999,380 Treatment of lipoprotein disorders associated with cholesterol metabolism | 8 | 1988 | |
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| 4,624,950 Method for treating atherosclerosis hyperlipidema, lipid deposition on arterial walls, or raising the ratio of high density lipoprotein cholesterol to total cholesterol in serum | 7 | 1984 | |
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| 5,025,012 Nicotinic acid derivatives and pharmaceutical compositions comprising same | 25 | 1990 | |
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| 5,032,406 Dual-action tablet | 42 | 1989 | |
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| 4,752,479 Multi vitamin and mineral dietary supplement with controlled release bioavailable iron | 59 | 1986 | |
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| 4,857,336 Oral therapeutic system having systemic action | 37 | 1987 | |
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| 4,973,468 Skin permeation enhancer compositions | 51 | 1989 | |
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| 4,839,177 System for the controlled-rate release of active substances | 96 | 1986 | |
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| 4,753,801 Sustained release tablets | 42 | 1985 | |
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| 4,824,677 Grooved tablet for fractional dosing of sustained release medication | 29 | 1986 | |
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| 5,132,116 Tablets of the hydrophilic matrix type based on salbutamol and a process for their preparation | 26 | 1991 | |
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| 4,824,672 Method and composition for reducing serum cholesterol | 49 | 1986 | |
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| 4,710,519 Process for preparing spray dried acetaminophen powder and the powder prepared thereby | 19 | 1985 | |
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| 4,994,267 Transdermal acrylic multipolymer drug delivery system | 84 | 1989 | |
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| 5,264,226 Process for preparing dairy products with a low content of sterols, particularly of cholesterol | 15 | 1991 | |
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| 4,842,863 Granular agent for ruminant and production method thereof | 41 | 1988 | |
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| 4,182,902 Novel cholesterol-lowering compounds | 7 | 1978 | |
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| 4,255,449 Method of treating abnormal lipoprote in ratios | 21 | 1979 | |
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| 4,996,058 Covered retard forms | 72 | 1988 | |
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| 4,970,081 Controlled-release, low-dose aspirin formulation and method of treating vascular occlusive disease therewith | 17 | 1989 | |
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| 4,452,775 Cholesterol matrix delivery system for sustained release of macromolecules | 127 | 1982 | |
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| 4,963,367 Drug delivery compositions and methods | 221 | 1987 | |
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| 4,794,115 Method of treating hyperlipemia | 6 | 1986 | |
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| 5,116,610 Compositions for treating hypercholesterolemia | 13 | 1991 | |
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| 4,866,058 Method for control of hyperlipidemia | 7 | 1988 | |
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| 5,178,854 Cholesterol-lowering agents | 9 | 1991 | |
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| 4,291,030 Method of lowering blood cholesterol | 9 | 1980 | |
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| 4,946,870 Delivery systems for pharmaceutical or therapeutic actives | 117 | 1988 | |
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| 4,920,115 Method of lowering LDL cholesterol in blood | 32 | 1988 | |
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| 4,237,118 Dietary supplement and dietary methods employing said supplement for the treatment of obesity | 39 | 1976 | |
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| 4,966,768 Sustained release etodolac | 24 | 1988 | |
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| 5,196,440 Compounds active as inhibitors of the cholesterol biosynthesis | 10 | 1990 | |
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| 4,696,762 Hydroxypropylmethylcellulose | 17 | 1985 | |
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| 4,784,858 Controlled release tablet | 58 | 1986 | |
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| 4,886,669 Galenical formulation | 48 | 1987 | |
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| 4,259,314 Method and composition for the preparation of controlled long-acting pharmaceuticals | 107 | 1979 | |
| 4,272,548 Process for the lowering of increased levels of cholesterol and neutral fat in the blood of humans | 17 | 1980 | |
| 4,268,524 Method of treating abnormal lipoprotein ratios with acylcarnitine | 10 | 1980 | |
| 4,455,298 Pharmaceutical preparations with gastro-protective action | 15 | 1982 | |
| 4,680,323 Method and composition for the preparation of controlled long-acting pharmaceuticals for oral administration | 33 | 1983 | |
| 4,764,374 Pharmaceutical composition based on guar gum and other antacids for protection of the oesogastroduodenal mucous membrane | 13 | 1986 | |
| 4,775,535 Method of preparing controlled long-acting pharmaceutical formulations in unit dosage form having uniform and comparable bioavailability characteristics | 22 | 1986 | |
| 4,882,167 Dry direct compression compositions for controlled release dosage forms | 62 | 1987 | |
| 4,855,143 Method of preparing controlled long-acting pharmaceutical formulations in unit dosage form having uniform and comparable bioavailability characteristics | 21 | 1988 | |
| 4,920,123 Method for controlling and/or lowering serum triglyceride and/or cholesterol levels in mammals | 14 | 1988 | |
| 5,110,817 Method for controlling and/or lowering serum triglyceride and/or cholesterol levels in mammals | 11 | 1990 | |
| 5,145,678 Method of reducing blood serum cholesterol | 13 | 1991 | |
Patent Citation Ranking
Maintenance Fees
| Fee | Large entity fee | small entity fee | micro entity fee | due date |
|---|---|---|---|---|
| 11.5 Year Payment | $7400.00 | $3700.00 | $1850.00 | Dec 8, 2015 |
| Fee | Large entity fee | small entity fee | micro entity fee |
|---|---|---|---|
| Surcharge - 11.5 year - Late payment within 6 months | $160.00 | $80.00 | $40.00 |
| Surcharge after expiration - Late payment is unavoidable | $700.00 | $350.00 | $175.00 |
| Surcharge after expiration - Late payment is unintentional | $1,640.00 | $820.00 | $410.00 |