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Crestor generic

Complete generic competition for Crestor (rosuvastatin): 20 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

20 approved generics Patents expired

About Crestor

Crestor (rosuvastatin) — originally marketed by AstraZeneca. Class: HMG-CoA reductase inhibitor (statin). First approved 2003-01-01.

Approved generic versions (20)

GenericManufacturerPhaseFirst approvalCountry
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)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing