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What s the difference between lipitor and approved generics?

See the DrugPatentWatch profile for lipitor

Lipitor, known generically as atorvastatin, is a prescription medication used to treat high cholesterol levels and reduce the risk of heart attack and stroke [1]. Lipitor is a brand-name drug produced by Pfizer, while approved generics are alternative versions of the drug that have been tested and approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) [2].

The primary difference between Lipitor and approved generics lies in the manufacturing and marketing of the drug. Lipitor is produced and marketed by Pfizer, while approved generics are produced by other pharmaceutical companies. However, both Lipitor and approved generics contain the same active ingredient, atorvastatin, and are required to have the same quality, strength, purity, and stability [2].

Generic drugs, including approved generics for Lipitor, are typically less expensive than brand-name drugs [3]. This is because generic drug manufacturers do not have to repeat the costly and time-consuming clinical trials required for FDA approval [3]. Instead, they can rely on the safety and efficacy data already established by the brand-name drug [3].

It is important to note that while approved generics are required to have the same active ingredient, excipients (inactive ingredients) may differ between brand-name and generic drugs [2]. However, these differences do not affect the safety or efficacy of the drug [2].

In summary, Lipitor and approved generics contain the same active ingredient, atorvastatin, and are required to have the same quality, strength, purity, and stability [2]. Approved generics are typically less expensive than Lipitor [3].

Sources:
[1] Mayo Clinic. (2021). Atorvastatin (Oral Route). Retrieved from <https://www.mayoclinic.org/drugs-supplements/atorvastatin-oral-route/description/drg-20065083>
[2] U.S. Food and Drug Administration. (2013). Generic Drugs: Questions and Answers. Retrieved from <https://www.fda.gov/drugs/understanding-generic-drugs/generic-drugs-questions-and-answers>
[3] U.S. Food and Drug Administration. (2021). Why are generic drugs less expensive? Retrieved from <https://www.fda.gov/drugs/generic-drugs/why-are-generic-drugs-less-expensive>
[4] DrugPatentWatch. (2021). Atorvastatin Calcium. Retrieved from <https://www.drugpatentwatch.com/drugs/atorvastatin-calcium>


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