Monday, October 24, 2016

Simcor


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


SIMCOR (niacin; simvastatin - tablet, extended release; oral)



  • Manufacturer: ABBOTT

    Approval date: February 15, 2008

    Strength(s): 1GM;20MG [RLD], 500MG;20MG [RLD], 750MG;20MG [RLD]


  • Manufacturer: ABBOTT

    Approval date: July 28, 2010

    Strength(s): 1GM;40MG [RLD], 500MG;40MG [RLD]

Has a generic version of Simcor been approved?


No. There is currently no therapeutically equivalent version of Simcor available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Simcor. 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
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • May 27, 2017
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • May 27, 2017
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA




  • 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
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA
      ✓ 
      Drug product


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
      ✓ 
      Drug product


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
      ✓ 
      Drug product




  • 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
      ✓ 
      Drug product




  • 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
      ✓ 
      Patent use: TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30 MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN THERAPY


    • March 15, 2018
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN


    • March 15, 2018
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN




  • 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
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT


    • September 20, 2013
      ✓ 
      Patent use: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT




  • 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
      ✓ 
      Drug product




  • 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
      ✓ 
      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: ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A) LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C


    • September 20, 2013
      ✓ 
      Patent use: TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C




  • 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: TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C


    • September 20, 2013
      ✓ 
      Patent use: TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • February 15, 2011 - NEW COMBINATION

See also...

  • Simcor Consumer Information (Drugs.com)
  • Simcor Consumer Information (Wolters Kluwer)
  • Simcor Consumer Information (Cerner Multum)
  • Simcor Advanced Consumer Information (Micromedex)
  • Simvastatin/Niacin Consumer Information (Wolters Kluwer)
  • Niacin and simvastatin Consumer Information (Cerner Multum)
  • Simvastatin and niacin Advanced Consumer Information (Micromedex)
Posted by at
Labels:

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)