Generic Zetia Availability

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

ZETIA (ezetimibe - tablet;oral)

  • Manufacturer: MSD INTL GMBH
    Approval date: October 25, 2002
    Strength(s): 10MG [RLD]

Has a generic version of Zetia been approved?

No. There is currently no therapeutically equivalent version of Zetia available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zetia. 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: TO REDUCE ELEVATED TOTAL-C, APO B, AND NON-HDL-C IN PATIENTS WIHT PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE IN COMBINATION WITH A STATIN
    • September 21, 2013
      ✓ 
      Patent use: TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
    • September 21, 2013
      ✓ 
      Patent use: TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS INCL SIMVASTATIN
    • March 21, 2014
      ✓ 
      Pediatric exclusivity
  • Sterol absorption inhibitor compositions
    Patent 7,030,106
    Issued: April 18, 2006
    Inventor(s): Cho; Wing-Kee Philip
    Assignee(s): Schering Corporation
    The present invention provides compositions, therapeutic combinations and methods including: (a) at least one peroxisome proliferator-activated receptor activator; and (b) at least one substituted azetidinone or substituted β-lactam sterol absorption inhibitor which can be useful for treating vascular conditions, diabetes, obesity and lowering plasma levels of sterols.
    Patent expiration dates:
    • January 25, 2022
      ✓ 
      Drug product
    • July 25, 2022
      ✓ 
      Pediatric exclusivity
  • Methods for inhibiting sterol absorption
    Patent 7,612,058
    Issued: November 3, 2009
    Inventor(s): Cho; Wing-Kee Philip
    Assignee(s): Schering Corporation
    The present invention provides compositions, therapeutic combinations and methods including: (a) at least one peroxisome proliferator-activated receptor activator; and (b) at least one substituted azetidinone or substituted β-lactam sterol absorption inhibitor which can be useful for treating vascular conditions, diabetes, obesity and lowering plasma levels of sterols.
    Patent expiration dates:
    • October 30, 2025
      ✓ 
      Patent use: REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
    • October 30, 2025
      ✓ 
      Patent use: TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
    • April 30, 2026
      ✓ 
      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
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 25, 2017
      ✓ 
      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 ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • 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:
    • January 24, 2015 - CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND RENAL PROTECTION (SHARP) TRIAL

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.
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