Wednesday, July 8, 2026

Drug profile · INN

rosuvastatin calcium

rosuvastatin calcium (ROSUVASTATIN CALCIUM) is a hmg-coa reductase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 2
Pipeline programs 3
News articles 0
Drug details — rosuvastatin calcium
US status
approved
Class
Route
ORAL
Patents
2
Programs
3
Data quality
0.89

Quick answer

rosuvastatin calcium (ROSUVASTATIN CALCIUM) is a hmg-coa reductase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN rosuvastatin calcium
Brand ROSUVASTATIN CALCIUM
Mechanism HMG-CoA reductase inhibitor
Target 3-hydroxy-3-methylglutaryl-coenzyme A reductase
Route ORAL
Formulation CAPSULE

Mechanism of action

HMG-CoA reductase inhibitor

Primary target: 3-hydroxy-3-methylglutaryl-coenzyme A reductase

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. CTO # 2095 Phase 3 · George Institute for · Venous thromboembolism, Pulmonary Embolism, Deep Vein Thromb
  2. Rosuvastatin Approved · Chinese Academy of · Infarction, Anterior Cerebral Artery
  3. Rosuvastatin Approved · First People's Hospital · Hyperlipidemia

Related & competitor drugs

  1. atorvastatin calcium HMG-CoA reductase inhibitor
  2. fluvastatin sodium HMG-CoA reductase inhibitor
  3. lovastatin HMG-CoA reductase inhibitor
  4. pitavastatin calcium HMG-CoA reductase inhibitor
  5. simvastatin HMG-CoA reductase inhibitor
  6. cerivastatin sodium HMG-CoA reductase inhibitor
  1. US 7994178

    Crystalline rosuvastatin calcium and compositions thereof for treatment of hyperlipidaemia

    Expires Mon Aug 04 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7396927

    Process for preparation of rosuvastatin calcium

    Expires Mon Jul 03 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is rosuvastatin calcium?

rosuvastatin calcium (ROSUVASTATIN CALCIUM) is a hmg-coa reductase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for rosuvastatin calcium?

ROSUVASTATIN CALCIUM is a marketed brand name for rosuvastatin calcium. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of rosuvastatin calcium?

rosuvastatin calcium has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.