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Crestor generic
About Crestor
Crestor (rosuvastatin) — originally marketed by AstraZeneca. Class: HMG-CoA reductase inhibitor (statin). First approved 2003-01-01.
Approved generic versions (20)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| ROSUVASTATIN | marketed | 2003-01-01 | ||
| Rosuvastatin Oral Tablet | Washington State University | marketed | ||
| Rosuvastatin-ranitidine | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | marketed | ||
| Rosuvastatin plus clopidogrel | Federal University of São Paulo | marketed | ||
| Rosuvastatin and fenofibrate | Gachon University Gil Medical Center | marketed | ||
| rosuvastatin 7 days | Radboud University Medical Center | marketed | ||
| Rosuvastatin; improvement of lipid profile | AstraZeneca | marketed | ||
| Rosuvastatin (Crestor) | Minneapolis Heart Institute Foundation | marketed | ||
| Rosuvastatin alone | Gachon University Gil Medical Center | marketed | ||
| Rosuvastatin-omeprazole | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | marketed | ||
| Rosuvastatin-esomeprazole | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | marketed | ||
| Rosuvastatin(Cresnon®) | Dong-A ST Co., Ltd. | marketed | ||
| rosuvastatin and clopidogrel | The Third Affiliated Hospital of Guangzhou Medical University | marketed | ||
| Rosuvastatin and Ezetimibe | Hanmi Pharmaceutical Company Limited | marketed | ||
| Rosuvastatin 20mg | AstraZeneca | marketed | ||
| Rosuvastatin plus ticagrelor | Federal University of São Paulo | marketed | ||
| Rosuvastatin calcium 40mg | Seung-Jung Park | marketed | ||
| Rosuvastatin or atorvastatin or simvastatin and clopidogrel | AstraZeneca | marketed | ||
| Rosuvastatin and Ezetimibe morning or evening administration | Collegium Medicum w Bydgoszczy | marketed | ||
| Rosuvastatin-pantoprazole | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.
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Related
- Crestor full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing