Crestor

Crestor is a prescription medicine brand based on rosuvastatin calcium, a synthetic statin used to reduce low-density lipoprotein cholesterol, or LDL-C, and other atherogenic lipids. It is marketed by AstraZeneca and belongs to the HMG-CoA reductase inhibitor class. Like other statins, rosuvastatin works primarily by inhibiting cholesterol synthesis in the liver and increasing the liver's clearance of circulating LDL particles. Rosuvastatin was discovered and developed by the Japanese pharmaceutical company Shionogi. AstraZeneca obtained development and commercialization rights in major markets and developed Crestor as an international cardiovascular medicine. The product received regulatory approval in the United States in 2003 and subsequently became available in a number of markets under the Crestor name, while rosuvastatin is also sold through generic and local-brand versions after patent and exclusivity periods expired. The brand's principal strengths are its high potency at comparatively low doses, its use across a broad range of hypercholesterolemia indications, and the clinical evidence supporting reductions in LDL-C and cardiovascular events when statin therapy is appropriately prescribed. Common tablet strengths include 5 mg, 10 mg, 20 mg, and 40 mg in markets where all of those strengths are approved. The 40 mg dose is generally reserved for patients requiring substantial LDL-C reduction or those at particularly high cardiovascular risk, subject to local labeling and medical supervision. Crestor has been used for primary hypercholesterolemia, mixed dyslipidemia, familial hypercholesterolemia, and prevention of major cardiovascular events in eligible patients. Treatment decisions depend on the patient's cardiovascular risk, lipid profile, comorbidities, other medicines, and applicable clinical guidelines. It is not a general wellness supplement and requires prescription oversight. Product labeling includes important contraindications and warnings, including risks involving muscle injury and liver effects, as well as restrictions during pregnancy and breastfeeding in accordance with local regulatory guidance. The brand became commercially important for AstraZeneca's cardiovascular portfolio and competed with other major statin brands, especially Lipitor, Zocor, and Pravachol, before and during the shift toward generic statin prescribing. AstraZeneca continued to market Crestor while also facing patent disputes, regulatory scrutiny typical of a widely used prescription medicine, and competition from lower-priced generic rosuvastatin. In the contemporary market, Crestor remains a recognized branded formulation, but its commercial position varies substantially by country because generic rosuvastatin is available in many jurisdictions.

Crestor is the commercial name used for rosuvastatin, a statin developed from research conducted by Shionogi in Japan. Rosuvastatin belongs to the same broad therapeutic class as atorvastatin, simvastatin, pravastatin, and other HMG-CoA reductase inhibitors, but it was developed as a potent, relatively hydrophilic compound with strong LDL-lowering activity. AstraZeneca secured rights to develop and commercialize the medicine in important international markets and made it part of its cardiovascular and metabolic-medicine portfolio. The product was introduced during a period of intense competition in the global statin market. AstraZeneca's objective was to establish rosuvastatin as a major branded alternative to atorvastatin and other established products. U.S. approval came in 2003, followed by approvals and launches in other jurisdictions. Initial labeling focused on treatment of hypercholesterolemia and mixed dyslipidemia, including several forms of familial hypercholesterolemia. The product was supplied as oral tablets in multiple strengths, allowing clinicians to adjust therapy according to baseline LDL-C, treatment response, tolerability, and cardiovascular risk. Clinical development and subsequent guideline use emphasized the extent of LDL-C reduction achievable with rosuvastatin. The medicine was also studied in people whose conventional lipid values did not by themselves place them in the highest-risk category but who had other indicators of vascular risk. The JUPITER trial evaluated rosuvastatin in apparently healthy participants with elevated high-sensitivity C-reactive protein and relatively low LDL-C. Its results supported a broader preventive-cardiology discussion and contributed to the FDA's 2010 approval of a cardiovascular-risk-reduction indication for a defined patient population. As the product gained adoption, Crestor became one of AstraZeneca's best-known cardiovascular brands. Its growth was supported by physician education, clinical evidence, international regulatory approvals, and a market need for potent LDL reduction. The brand also attracted debate common to large cardiovascular-drug franchises, including questions about the interpretation of clinical-trial evidence, appropriate treatment thresholds, safety monitoring, and the cost of branded therapy. Regulatory authorities continued to require warnings and precautions concerning myopathy, rhabdomyolysis, liver effects, renal considerations, drug interactions, and use during pregnancy. Crestor's commercial life was shaped by intellectual-property litigation and the eventual arrival of generic rosuvastatin. AstraZeneca defended patents and regulatory exclusivities in multiple markets, while generic manufacturers pursued approval and market entry. In the United States, generic competition became commercially significant in the mid-2010s. This shifted prescribing and reimbursement dynamics: the active ingredient remained widely used, but branded Crestor faced pressure from lower-cost alternatives and payer substitution. Today, Crestor is best understood as a mature global prescription brand rather than a newly introduced product. AstraZeneca continues to maintain branded versions in markets where they remain commercially available, while rosuvastatin is also supplied by numerous generic manufacturers. The brand's identity remains associated with high-potency statin therapy, LDL-C reduction, and the broader prevention of atherosclerotic cardiovascular disease under medical supervision.

• 2016

  U.S. generic competition

  [4]FDA information on rosuvastatin calciumfda.gov

  Generic rosuvastatin became available in the United States, increasing competition with branded Crestor.

• 2010

  Expanded cardiovascular-risk indication

  [2]FDA approval of expanded Crestor cardiovascular indicationfda.gov

  The FDA approved expanded labeling for Crestor for reducing certain major cardiovascular events in an eligible population.

• 2008

  JUPITER trial results published

  [3]JUPITER clinical trial publicationnejm.org

  The JUPITER study reported cardiovascular-event reductions among selected participants treated with rosuvastatin, contributing to later regulatory and clinical discussions.

• 2003

  U.S. regulatory approval

  [1]Crestor U.S. prescribing informationaccessdata.fda.gov

  The FDA approved Crestor (rosuvastatin calcium) for specified cholesterol-lowering indications.

A high-potency prescription statin positioned for LDL-cholesterol reduction and cardiovascular-risk management.

• Prescription statin · 2003

  Crestor tablets

  The core Crestor product is an oral tablet containing rosuvastatin calcium. It is prescribed to lower LDL cholesterol and other atherogenic lipid measures and, for specified patients, to reduce the risk of major cardiovascular events. Tablet strengths and approved indications vary by jurisdiction. Treatment requires assessment of cardiovascular risk, potential interactions, contraindications, and safety considerations.

• Dose-strength range · 2003

  Crestor 5 mg, 10 mg, 20 mg, and 40 mg tablets

  Crestor has been supplied in several dose strengths to support individualized statin treatment. Lower strengths may be used when initiating therapy, adjusting for response or tolerability, or treating patients with particular risk factors. Higher strengths provide more intensive LDL lowering but are used under prescribing guidance because statin-related adverse effects and interactions must be considered.

• 2016

  Response to generic market entryOther

  Background

  Expiration of relevant exclusivity and patent protections enabled generic rosuvastatin manufacturers to seek and obtain U.S. market access.

  Action taken

  The market moved from predominantly branded Crestor supply toward competition between AstraZeneca's brand and generic rosuvastatin products.

  Aftermath

  Generic substitution and payer pressure reduced the commercial exclusivity of the Crestor brand, although rosuvastatin remained an important active ingredient.

  Source

• 2010

  Expansion into cardiovascular-risk reductionStrategy

  Background

  Clinical evidence from the JUPITER trial examined rosuvastatin in selected people who did not have clinically apparent cardiovascular disease but had elevated high-sensitivity C-reactive protein and additional risk factors.

  Action taken

  U.S. regulators approved expanded Crestor labeling for reducing the risk of specified major cardiovascular events in an eligible population.

  Aftermath

  The decision broadened the product's preventive-cardiology positioning while leaving patient selection and treatment decisions subject to regulatory labeling and clinical judgment.

  Source

• 2026.09.22

  Reported2026.10.24

  Morocco approves price reductions for medicines[5]摩洛哥批准下调药品价格moroccoworldnews.com

  Morocco approved price reductions for 22 pharmaceutical presentations across eight medicine brands under a ministerial order signed on September 22. The changes include price cuts for Alecensa, Avastin, Actemra, Advagraf, Crestor, Apxia and Bestor.

Read more

1. 1Crestor U.S. prescribing informationaccessdata.fda.gov
2. 2FDA approval of expanded Crestor cardiovascular indicationfda.gov
3. 3JUPITER clinical trial publicationnejm.org
4. 4FDA information on rosuvastatin calciumfda.gov
5. 5摩洛哥批准下调药品价格moroccoworldnews.com