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Lipitor biosimilars

Complete Lipitor (atorvastatin) biosimilar landscape: 28 approved biosimilars, 0 filed, 3 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

28 approved 0 filed 3 Phase 3 2 active patents

About Lipitor

Lipitor (atorvastatin) — originally marketed by Pfizer Inc.. Class: HMG-CoA reductase inhibitor (statin). Target: HMG-CoA reductase. Area: Metabolic. First approved 1996-12-17.

Approved biosimilars (28)

BiosimilarSponsorPhaseFirst approvalCountry
Atorvastatin (generic Lipitor) University of Pennsylvania marketed
atorvastatin,pravastatin Shenyang Northern Hospital marketed
Atorvastatin, Amlodipine, Perindopril Charles University, Czech Republic marketed
Atorvastatin, high vs low dose Hippocration General Hospital marketed
Atorvastatin B Hanmi Pharmaceutical Company Limited marketed
Atorvastatin-pantoprazole Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec marketed
Atorvastatin and Omega-3 fatty acids Pfizer's Upjohn has merged with Mylan to form Viatris Inc. marketed
Atorvastatin and fenofibrate The University of Western Australia marketed
Atorvastatin-esomeprazole Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec marketed
Atorvastatin (Lipinon) Seoul National University Hospital marketed
Atorvastatin, Ezetimibe Abant Izzet Baysal University marketed
atorvastatin plus ezetimibe Shanghai Jiao Tong University School of Medicine marketed
Atorvastatin (Lipilou) Chong Kun Dang Pharmaceutical marketed
atorvastatin and clopidogrel Ospedale Misericordia e Dolce marketed
Atorvastatin (Lipitor) University of Chicago marketed
Atorvastatin, Probucol, Cilostazol Otsuka Beijing Research Institute marketed
Atorvastatin-ranitidine Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec marketed
atorvastatin 3 days Radboud University Medical Center marketed
Atorvastatin Calcium tablets 80mg Sichuan Provincial People's Hospital marketed
Atorvastatin 10mg Copenhagen University Hospital, Hvidovre marketed
Atorvastatin 80 mg Organon and Co marketed
Atorvastatin or Rosuvastatin Wenzhou Medical University marketed
Atorvastatin 10 mg Organon and Co marketed
atorvastatin 7 days Radboud University Medical Center marketed
Atorvastatin A Hanmi Pharmaceutical Company Limited marketed
Atorvastatin Calcium Tablets NYU Langone Health marketed
Atorvastatin-omeprazole Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec marketed
atorvastatin, aspirin, losartan, amlodipine Russian Cardiology Research and Production Center marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (3)

BiosimilarSponsorPhaseFirst approvalCountry
Atorvastatin Calcium 20mg, QD Kuhnil Pharmaceutical Co., Ltd. phase 3
Atorvastatin alone Wenzhou Medical University phase 3
Atorvastatin 40mg, QD Daewoong Pharmaceutical Co. LTD. phase 3

Originator patent timeline

Active patents (2)

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Lipitor or any of its biosimilars:

Related

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