Generic Crestor Availability

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

CRESTOR (rosuvastatin calcium - tablet; oral)

  • Manufacturer: IPR
    Approval date: August 12, 2003
    Strength(s): 10MG, 20MG, 40MG [RLD], 5MG

Has a generic version of Crestor been approved?

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

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

  • Pharmaceutical compositions
    Patent 6,316,460
    Issued: November 13, 2001
    Inventor(s): Creekmore; Joseph R & Wiggins; Norman A.
    Assignee(s): Astrazeneca AB
    The invention concerns a pharmaceutical composition comprising the HMG CoA reductase inhibitor (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrim idin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically acceptable salt thereof as the active ingredient, which remains stable over a prolonged period.
    Patent expiration dates:
    • August 4, 2020
      ✓ 
      Drug product
    • February 4, 2021
      ✓ 
      Pediatric exclusivity
  • Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
    Patent 6,858,618
    Issued: February 22, 2005
    Inventor(s): Raza; Ali & Hutchinson; Howard Gerard
    Assignee(s): AstraZeneca AB
    The invention provides a method for the treatment of heterozygous familial hypercholesterolemia by administering the compound (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid or a pharmaceutically acceptable salt thereof.
    Patent expiration dates:
    • December 17, 2021
      ✓ 
      Patent use: USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR TG LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS.
    • June 17, 2022
      ✓ 
      Pediatric exclusivity
  • Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
    Patent 7,030,152
    Issued: April 18, 2006
    Inventor(s): Ridker; Paul & Hennekens; Charles H.
    Assignee(s): The Brigham and Women's Hospital, Inc.
    The invention involves methods for characterizing an individual's risk profile of developing a future cardiovascular disorder by obtaining a level of the marker of systemic inflammation in the individual. The invention also involves methods for evaluating the likelihood that an individual will benefit from treatment with an agent for reducing the risk of future cardiovascular disorder.
    Patent expiration dates:
    • April 2, 2018
      ✓ 
      Patent use: USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH INCREASED RISK FACTORS
    • October 2, 2018
      ✓ 
      Pediatric exclusivity
  • Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
    Patent 7,964,614
    Issued: June 21, 2011
    Inventor(s): Ridker; Paul & Hennekens; Charles H.
    Assignee(s): The Brigham and Women's Hospital, Inc.
    The invention involves methods for characterizing an individual's risk profile of developing a future cardiovascular disorder by obtaining a level of the marker of systemic inflammation in the individual. The invention also involves methods for evaluating the likelihood that an individual will benefit from treatment with an agent for reducing the risk of future cardiovascular disorder.
    Patent expiration dates:
    • April 2, 2018
      ✓ 
      Patent use: USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH INCREASED RISK FACTORS
    • October 2, 2018
      ✓ 
      Pediatric exclusivity
  • Pyrimidine derivatives
    Patent RE37314
    Issued: August 7, 2001
    Inventor(s): Hirai; Kentaro & Ishiba; Teruyuki & Koike; Haruo & Watanabe; Masamichi
    Assignee(s): Shionogi Seiyaku Kabushiki Kaisha
    The compounds of the present invention inhibit the HMG-CoA reductase, and subsequently suppress the biosynthesis of cholesterol. And they are useful in the treatment of hypercholesterolemia, hyperlipoproteinemia, and atherosclerosis.
    Patent expiration dates:
    • January 8, 2016
      ✓ 
      Drug substance
    • July 8, 2016
      ✓ 
      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:
    • October 16, 2012 - TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5 TO 20 MG ONCE DAILY
    • February 8, 2013 - PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE, BASED ON THE RESULTS OF JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION; AN INTERVENTION TRIAL EVALUATING ROSUVASTATIN (JUPITER)
    • April 16, 2013 - PEDIATRIC EXCLUSIVITY

See also...

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.
Advertisement
Close

Recommended

(web1)