Saturday, July 11, 2026

Drug profile · INN

rosuvastatin

rosuvastatin (APO-ROSUVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd.

TGA: approved NMPA: clinical trials
Patents linked 9
Pipeline programs 33
News articles 0
Drug details — rosuvastatin

Quick answer

rosuvastatin (APO-ROSUVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd.

Key facts

INN rosuvastatin
Brand APO-ROSUVASTATIN
Mechanism HMG-CoA reductase inhibitor

Mechanism of action

HMG-CoA reductase inhibitor

Approval history

Authority Status Date
TGA approved
NMPA clinical trials

Pipeline programs

  1. CKJX839A12309 Phase 3 · Novartis India · Acute coronary syndrome (ST-elevation myocardial infarction
  2. CKJX839B12302 Phase 3 · Novartis India · Atherosclerotic cardiovascular disease (ASCVD)
  3. CKJX839D12303 Phase 3 · Novartis India · Non-obstructive Coronary Artery Disease
  4. CTO # 2095 Phase 3 · George Institute for · Venous thromboembolism, Pulmonary Embolism, Deep Vein Thromb
  5. Fimasartan and Rosuvastatin Phase 3 · Yung Shin Pharmaceutical · Essential Hypertension, Dyslipidemia
  6. Lapaquistat acetate and rosuvastatin Phase 3 · Takeda · Hypercholesterolemia
  7. MK-0616-037 Phase 3 · MSD Merck Sharp · Hyperlipidemia
  8. PCSK9 inhibitors combined with atorvastatin/rosuvastatin Phase 3 · Chinese Academy of · Acute Ischemic Stroke
  1. US 8487097

    Reference standard for characterization of rosuvastatin

    Expires Mon Jul 11 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8063211

    Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof

    Expires Mon Nov 17 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 7741482

    Reference standard for characterization of rosuvastatin

    Expires Mon Jun 17 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 7692009

    Reference standard for characterization of rosuvastatin

    Expires Mon Apr 01 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 7692008

    Reference standard for characterization of rosuvastatin

    Expires Mon Apr 01 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 7692010

    Reference standard for characterization of rosuvastatin

    Expires Mon Apr 01 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 7612203

    Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof

    Expires Mon Oct 29 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 7582759

    Diastereomeric purification of rosuvastatin

    Expires Mon Aug 27 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 7244844

    Reference standard for characterization of rosuvastatin

    Expires Mon Jul 12 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is rosuvastatin?

rosuvastatin (APO-ROSUVASTATIN) is a hmg-coa reductase inhibitor. Associated with Alphapharm Pty Ltd.

What is the brand name for rosuvastatin?

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