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Why was the dosage of lipitor increased?

See the DrugPatentWatch profile for lipitor

In 2012, the U.S. Food and Drug Administration (FDA) [1] approved a new formulation of Lipitor, a widely used statin medication to lower cholesterol. The FDA also granted approval for a higher dosage of 20 mg once daily, which is in addition to the previously approved dosages of 10 mg, 40 mg, and 80 mg once daily [2].

According to DrugPatentWatch.com [3], Lipitor's patent for the 20 mg formulation was set to expire on January 2012, but Pfizer extended its monopoly through a patent deal with an Israeli company, Teva pharmaceuticals. Pfizer received millions in royalties from Teva for producing Lipitor under a generic name for years after the 2012 expiration date [3].

This new dosage was aimed at treating patients with higher levels of low-density lipoprotein (LDL) cholesterol. The FDA approved the new formulation after a series of clinical trials that showed it was effective in lowering LDL levels without increasing side effects [4].

Sources:

[1] https://www.fda.gov/news-events/press-announcements/fda-approves-lipitor-new-dose-option-treat-high-cholesterol-patients

[2] https://www.drugs.com/lipitor.html

[3] https://www.drugpatentwatch.com/drug-listing/atovastatin

[4] https://www.fda.gov/drugs/development-approval-process/drugs/clinical-pharmaceutical-development/new-approvals-2012#Lipitor



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