Vytorin

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

VYTORIN (ezetimibe; simvastatin - tablet; oral)

• 
  Manufacturer: MSD INTL
  
  Approval date: July 23, 2004
  
  Strength(s): 10MG;10MG, 10MG;20MG, 10MG;40MG, 10MG;80MG ^[RLD]

Has a generic version of Vytorin been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vytorin. 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.

• 
  Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors
  Patent 5,846,966
  Issued: December 8, 1998
  Inventor(s): Rosenblum; Stuart B. & Dugar; Sundeep & Burnett; Duane A. & Clader; John W. & McKittrick; Brian A.
  Assignee(s): Schering Corporation
  Hydroxy-substituted azetidinone hypocholesterolemic agents of the formula ##STR1## or a pharmaceutically acceptable salt thereof, wherein: Ar.sup.1 and Ar.sup.2 are aryl or R.sup.4 -substituted aryl; Ar.sup.3 is aryl or R.sup.5 -substituted aryl; X, Y and Z are --CH.sub.2 --, --CH(lower alkyl)-- or --C(dilower alkyl)--; R and R.sup.2 are --OR.sup.6, --O(CO)R.sup.6, --O(CO)OR.sup.9 or --O(CO)NR.sup.6 R.sup.7 ; R.sup.1 and R.sup.3 are H or lower alkyl; q is 0 or 1; r is 0 or 1; m, n and p are 0-4; provided that at least one of q and r is 1, and the sum of m, n, p, q and r is 1-6; and provided that when p is 0 and r is 1, the sum of m, q and n is 1-5; R.sup.4 is selected from lower alkyl, R.sup.5, --CF.sub.3, --CN, --NO.sub.2 and halogen; R.sup.5 is selected from --OR.sup.6, --O(CO)R.sup.6, --O(CO)OR.sup.9, --O(CH.sub.2).sub.1-5 OR.sup.6, --O(CO)NR.sup.6 R.sup.7, --NR.sup.6 R.sup.7, --NR.sup.6 (CO)R.sup.7, --NR.sup.6 (CO)OR.sup.9, --NR.sup.6 (CO)NR.sup.7 R.sup.8, --NR.sup.6 SO.sub.2 R.sup.9, --COOR.sup.6, --CONR.sup.6 R.sup.7, --COR.sup.6, --SO.sub.2 NR.sup.6 R.sup.7, S(O).sub.0-2 R.sup.9, --O(CH.sub.2).sub.1-10 --COOR.sup.6, --O(CH.sub.2).sub.1-10 CONR.sup.6 R.sup.7, --(lower alkylene)COOR.sup.6 and --CH.dbd.CH--COOR.sup.6 ; R.sup.6, R.sup.7 and R.sup.8 are H, lower alkyl, aryl or aryl-substituted lower alkyl; R.sup.9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them, and a process for preparing them.
  
  Patent expiration dates:
  
  
  • September 21, 2013
    
    ✓ 
    Patent use: TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
    ✓ 
    Drug product
  
  
  
  • September 21, 2013
    
    ✓ 
    Patent use: TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
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    Drug product
  
  
  
  • March 21, 2014
    
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    Pediatric exclusivity
  
  



• 
  Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
  Patent RE37721
  Issued: May 28, 2002
  Inventor(s): Stuart B.; Rosenblum & Sundeep; Dugar & Duane A.; Burnett & John W.; Clader & Brian A.; McKittrick
  Assignee(s): Schering Corporation
  Hydroxy-substituted azetidinone hypocholesterolemic agents of the formula or a pharmaceutically acceptable salt thereof, wherein: Ar1 and Ar2 are aryl or R4-substituted aryl; Ar3 is aryl or R5-substituted aryl; X, Y and Z are —CH2—, —CH(lower alkyl)— or —C(dilower alkyl)—; R and R2 are —OR6, —O(CO)R6, —O(CO)OR9 or —O(CO)NR6R7; R1 and R3 are H or lower alkyl; q is 0 or 1; r is 0 or 1; m, n and p are 0-4; provided that at least one of q and r is 1, and the sum of m, n, p, q and r is 1-6; and provided that when p is O and r is 1, the sum of m, q and n is 1-5; R4 is selected from lower alkyl, R5, —CF3, —CN, —NO2 and halogen R5 is selected from —OR6, —O(CO)R6, —O(CO)OR9, —O(CH2)1-5OR6, —O(CO)NR6R7, —NR6R7, —NR6(CO)R7, —NR6(CO)OR9, —NR6(CO)NR7R8, —NR6SO2R9, —COOR6, —CONR6R7, —COR6, —SO2NR6R7, S(O)0-2R9, —O(CH2)1-10—COOR6, —O(CH2)1-10CONR6R7, —(lower alkylene)COOR6 and —CH═CH—COOR6; R6, R7 and R8 are H, lower alkyl or aryl-substituted Ic R9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them; and a process for preparing them.
  
  Patent expiration dates:
  
  
  • October 25, 2016
    
    ✓ 
    Patent use: TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
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    Drug substance
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    Drug product
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    Sponsor has requested patent be delisted
  
  
  
  • April 25, 2017
    
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    Pediatric exclusivity
  
  



• 
  Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
  Patent RE42461
  Issued: June 14, 2011
  Inventor(s): Rosenblum; Stuart B. & Dugar; Sundeep & Burnett; Duane A. & Clader; John W. & McKittrick; Brian A.
  Assignee(s): Schering Corporation
  Hydroxy-substituted azetidinone hypocholesterolemic agents of the formula or a pharmaceutically acceptable salt thereof, wherein: Ar1 and Ar2 are aryl or R4-substituted aryl; Ar3 is aryl or R5-substituted aryl; X, Y and Z are —CH2—, —CH(lower alkyl)— or —C(dilower alkyl)—; R and R2 are —OR6, —O(CO)R6, —O(CO)OR9 or —O(CO)NR6R7; R1 and R3 are H or lower alkyl; q is 0 or 1; r is 0 or 1; m, n and p are 0-4; provided that at least one of q and r is 1, and the sum of m, n, p, q and r is 1-6; and provided that when p is O and r is 1, the sum of m, q and n is 1-5; R4 is selected from lower alkyl, R5, —CF3, —CN, —NO2 and halogen R5 is selected from —OR6, —O(CO)R6, —O(CO)OR9, —O(CH2)1-5OR6, —O(CO)NR6R7, —NR6R7, —NR6(CO)R7, —NR6(CO)OR9, —NR6(CO)NR7R8, —NR6SO2R9, —COOR6, —CONR6R7, —COR6, —SO2NR6R7, S(O)0-2R9, —O(CH2)1-10—COOR6, —O(CH2)1-10CON6R7, —(lower alkylene)COOR6 and —CH═CH—COOR6; R6, R7 and R8 are H, lower alkyl or aryl-substituted Ic R9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them; and a process for preparing them.
  
  Patent expiration dates:
  
  
  • October 25, 2016
    
    ✓ 
    Patent use: TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  
  
  • April 25, 2017
    
    ✓ 
    Pediatric exclusivity
  
  

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:
  • June 5, 2011 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
  
  
  • December 5, 2011 - PEDIATRIC EXCLUSIVITY
  
  
  • January 24, 2015 - CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND RENAL PROTECTION (SHARP) TRIAL
  
  

See also...

• Vytorin Consumer Information (Drugs.com)
• Vytorin Consumer Information (Wolters Kluwer)
• Vytorin Consumer Information (Cerner Multum)
• Vytorin Advanced Consumer Information (Micromedex)
• Ezetimibe/Simvastatin Consumer Information (Wolters Kluwer)
• Ezetimibe and simvastatin Consumer Information (Cerner Multum)
• Ezetimibe and simvastatin Advanced Consumer Information (Micromedex)