Generic Niaspan Availability

Niaspan is a brand name of niacin, approved by the FDA in the following formulation(s):

NIASPAN (niacin - tablet, extended release;oral)

  • Manufacturer: ABBVIE
    Approval date: July 28, 1997
    Strength(s): 1GM [RLD] [AB], 500MG [AB], 750MG [RLD] [AB]

Has a generic version of Niaspan been approved?

A generic version of Niaspan has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Niaspan and have been approved by the FDA:

niacin tablet, extended release;oral

  • Manufacturer: BARR
    Approval date: April 14, 2005
    Strength(s): 1GM [AB]
  • Manufacturer: BARR
    Approval date: April 26, 2005
    Strength(s): 500MG [AB], 750MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: March 20, 2014
    Strength(s): 1GM [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: April 23, 2014
    Strength(s): 1GM [AB], 500MG [AB], 750MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Niaspan. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 6,080,428
    Issued: June 27, 2000
    Inventor(s): Bova; David J.
    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.
    Patent expiration dates:
    • May 27, 2017
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      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • May 27, 2017
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      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • May 27, 2017
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      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • May 27, 2017
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      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • May 27, 2017
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      Patent use: METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
  • Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night
    Patent 6,129,930
    Issued: October 10, 2000
    Inventor(s): Bova; David J.
    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.
    Patent expiration dates:
    • September 20, 2013
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      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
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      Drug product
    • September 20, 2013
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      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
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      Drug product
    • September 20, 2013
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      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
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      Drug product
    • September 20, 2013
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      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
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      Drug product
    • September 20, 2013
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      Patent use: METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
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      Drug product
    • September 20, 2013
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      Patent use: METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
  • Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles
    Patent 6,406,715
    Issued: June 18, 2002
    Inventor(s): Eugenio A.; Cefali
    Assignee(s): Kos Pharmaceuticals, Inc.
    Intermediate release nicotinic acid formulations having unique urinary metabolite profiles, which are suitable for oral administration once-a-day as a single dose during a 24 hour period for treating hyperlipidemia without causing drug-induced hepatotoxicity or drug-induced elevations in uric acid or glucose or both to levels that require the therapy to be discontinued, are disclosed.
    Patent expiration dates:
    • September 20, 2013
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      Patent use: INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
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      Drug product
    • September 20, 2013
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      Patent use: INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
  • Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acid
    Patent 6,469,035
    Issued: October 22, 2002
    Inventor(s): Eugenio A.; Cefali
    The present invention relates to pretreating individuals with an effective amount of a flush inhibiting agent for a sufficient period of time prior to the start of single daily dose nicotinic acid therapy to reduce the capacity of nicotinic acid to induce flushing reactions in such individuals during nicotinic acid therapy. In accordance with the present invention, the flush inhibiting agents are administered orally one to four times a day, and preferably one to two times per day, for between about 7 to about 14 days prior to the start of the nicotinic acid therapy. Examples of flush inhibiting agents include nonsteroidal anti-inflammatory agents. Aspirin is a preferred flush inhibiting agent and may be orally administered in daily doses of between about 80 mg to about 1000 mg, and preferably between about 80 mg and about 650 mg, and more preferably between about 80 mg and about 325 mg, during the pretreatment period. Also consistent with the present invention, the pretreatment therapy may be continued during and administered concurrently with the nicotinic acid therapy, in which the nicotinic acid is preferably administered once per day as a single dose during the evening hours or before or at bedtime. The nicotinic acid may be administered alone or in combination with HMG-CoA reductase inhibitors as well as other lipid-altering agents, like cholestyramine and colestipol.
    Patent expiration dates:
    • March 15, 2018
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      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR A T NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
    • March 15, 2018
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      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
    • March 15, 2018
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      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
    • March 15, 2018
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      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
    • March 15, 2018
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      Patent use: A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
  • Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia
    Patent 6,676,967
    Issued: January 13, 2004
    Inventor(s): Eugenio A.; Cefali & David J.; Bova
    Assignee(s): KOS Pharmaceuticals, Inc.
    Methods for reducing flushing in individuals being treated for hyperlipidemia with nicotinic acid are disclosed. According to the methods of the present invention, flushing can be reduced in individuals under going nicotinic acid therapy without causing drug-induced hepatotoxicity to a level that would require the nicotinic acid therapy to be discontinued by orally administering to the individuals intermediate nicotinic acid formualtions having unique biopharmaceutical characteristics as a single dose once per day. While the methods of the present invention contemplate administering the intermediate release nicotinic acid formulations at any time during a 24 hour period, it is preferable to administer them once-a-day as a single dose during the evening or at night between about 6:00 pm. and 12:00 a.m., preferably between about 8:00 p.m. and 12:00 a.m., and most preferably between about 8:00 p.m. and 10:00 p.m.
    Patent expiration dates:
    • September 20, 2013
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      Patent use: REDUCTION IN TG WITH REDUCED FLUSHING BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
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      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
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      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
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      Patent use: A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER AND EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
  • Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
    Patent 6,746,691
    Issued: June 8, 2004
    Inventor(s): Eugenio A.; Cefali
    Assignee(s): Kos Pharmaceuticals, Inc.
    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 F2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F2 of at least 44.
    Patent expiration dates:
    • September 20, 2013
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      Patent use: AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL ADMINISTRATION ONCE-A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
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      Drug product
    • September 20, 2013
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      Patent use: AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL ADMINISTRATION ONCE-A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
  • Intermediate release nicotinic acid compositions for treating hyperlipidemia
    Patent 6,818,229
    Issued: November 16, 2004
    Inventor(s): Eugenio A.; Cefali & David J.; Bova
    Assignee(s): KOS Pharmaceuticals, Inc.
    Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, such as Cmax, Tmax and AUC, which are suitable for oral administration once per day 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.
    Patent expiration dates:
    • September 20, 2013
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      Drug product
    • February 15, 2014
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      Drug product
  • Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 7,011,848
    Issued: March 14, 2006
    Inventor(s): Bova; David J.
    Assignee(s): KOS Pharmaceuticals, Inc.
    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.
    Patent expiration dates:
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
    • September 20, 2013
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      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTINO OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
    • September 20, 2013
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      Patent use: A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA
  • Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
    Patent 7,998,506
    Issued: August 16, 2011
    Inventor(s): Bova; David J
    Assignee(s): KOS Life Sciences, Inc.
    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.
    Patent expiration dates:
    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
    • September 20, 2013
      ✓ 
      Patent use: REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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