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Generic Crestor Availability

Last updated on July 7, 2021.

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): EQ 5MG BASE [RLD] [AB], EQ 10MG BASE [RLD] [AB], EQ 20MG BASE [RLD] [AB], EQ 40MG BASE [RLD] [AB]

Has a generic version of Crestor been approved?

A generic version of Crestor 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 Crestor and have been approved by the FDA:

rosuvastatin calcium tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: March 21, 2017
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: ALLIED
    Approval date: July 19, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 19, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: BIOCON LTD
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: CADILA PHARMS LTD
    Approval date: November 23, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: CHANGZHOU PHARM
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: GLENMARK PHARMS
    Approval date: July 19, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: LUPIN
    Approval date: July 31, 2017
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: MSN
    Approval date: November 22, 2017
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: RENATA
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: SANDOZ INC
    Approval date: July 19, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: SHANDONG
    Approval date: May 7, 2019
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: July 19, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: TORRENT
    Approval date: October 31, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: April 29, 2016
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: ZHEJIANG YONGTAI
    Approval date: November 4, 2019
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 40MG BASE [AB]

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: Generic Drug FAQ.

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:

    • 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.
    • December 17, 2021
      ✓ 
      Patent use: TREATMENT OF PEDIATRIC PATIENTS 8 TO 17 YEARS OF AGE WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
    • December 17, 2021
      ✓ 
      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
    • June 17, 2022
      ✓ 
      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:

    • May 27, 2023 -

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.