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Lipitor generic

Complete generic competition for Lipitor (atorvastatin): 28 approved generics across manufacturers, 0 filed under FDA review. 2 active patents remain. Sourced from FDA Orange Book + USPTO.

28 approved generics 2 active patents

About Lipitor

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

Approved generic versions (28)

GenericManufacturerPhaseFirst approvalCountry
Atorvastatin (generic Lipitor) University of Pennsylvania marketed
atorvastatin, aspirin, losartan, amlodipine Russian Cardiology Research and Production Center 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,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-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

Originator patent timeline

Active patents (2)

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