Ranbaxy gets FDA approval to launch Lipitor's generic version in US
Ranbaxy Pharmaceuticals Inc., India's largest drugmaker, announced that it has received final approval from the US Food and Drug Administration (USFDA) to launch the most sought-after generic version of Lipitor (called atorvastatin) in the US market. Lipitor is the blockbuster cholesterol-lowering drug manufactured by Pfizer Inc.
Ranbaxy is the first company to get USFDA authorization (first-to-file status) to manufacture generic copy of the patented drug Lipitor. And Ranbaxy has been granted exclusive rights by the FDA to market atorvastatin for 180 days. With this deal, Ranbaxy could fetch millions of dollars in revenue and it is estimated that, during this period, Ranbaxy could generate profit of about $650 million.
Lipitor is the world's top-selling anti-cholesterol drug that is widely used by millions of people to manage high cholesterol levels over time. This drug lowers bad cholesterol levels and it can raise good cholesterol levels as well. For Americans, FDA's permission to manufacture and market generic drug atorvastatin in the US comes in as an affordable alternative treatment to branded Lipitor in lowering their cholesterol levels.