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Lipitor generic
About Lipitor
Lipitor (atorvastatin) — originally marketed by Pfizer Inc.. Class: HMG-CoA reductase inhibitor (statin). First approved 1996-12-17.
Approved generic versions (28)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
- —
11654106· US - —
11369567· US
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
- Lipitor 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