Indian pharmaceutical firm Lupin has got USFDA approval for selling its generic version of cholesterol drug Lipitor in the US, it said in a statement. Lipitor, Pfizer s cholesterol-reducing tablet is the best selling prescription drug in the world history, which, by some estimates, has brought over $125 billion in revenues for Pfizer. Lupin can now market in the US its Atorvastatin Calcium tablet, which is a generic version of Pfizer s Lipitor.
Atorvastatin Calcium tablets — the generic Lipitor — had annual sales of $696 million in the US last year. Lupin said that its generic tablet available in USP 10 mg, 20 mg, 40 mg, and 80 mg, is indicated to lower blood cholesterol among children aged above 10 years and adults. Atorvastatin is also prescribed to lower the risk for heart attack, stroke in patients with cardiovascular diseases, diabetes and other risk factors such as eye problems, kidney diseases or high blood pressure, the company added.
Lupin is the 8th largest generics pharmaceutical company in India in terms of market capitalisation and in terms of market revenue globally. The company is also the 3rd largest player in the US in terms of the total market of pharmaceutical companies.
Previously, Indian pharmaceutical brand Ranbaxy had got the approval to sell Lipitor s generic tablet in October 2011. However, it had to recall over 64,000 units of the product once in 2012 and again in 2014 following complaints of substandard production by Ranbaxy and mixing it up with other drugs. In 2013, Ranbaxy had to pay fine to the US government to settle criminal and civil charges against it. Ranbaxy was banned to ship to the US any pharmaceuticals from certain Indian plants.
After Ranbaxy was sold to Sun Pharma in 2014 in a merger, the USFDA had banned Sun Pharma products as well in the US.