Aurobindo Pharma has received tentative approval for rosuvastatin calcium tablets 5mg, 10 mg, 20mg and 40 mg from the US FDA. Rosuvastatin calcium tablets are the generic equivalent of IPR Pharmaceuticals Inc's Crestor tablets 5mg, 10 mg, 20mg and 40 mg. Rosuvastatin Calcium is indicated for the treatment of high LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia) and falls under the CardioVascular (CVS) therapeutic category. The product has a market size of about US$ 2.9 billion for the year ended December 2009 as per Newport.
The tentatively approved ANDA No 079170 for rosuvastatin calcium tablets 5mg, 10 mg, 20mg and 40 mg was filed with Paragraph IV certification with the first to file status and is currently under litigation in the united states district court for the district of Delaware [AstraZenca Pharmaceuticals LP, AstraZenca UK, IPR Pharmaceuticals Inc' and Shionogi Seiaku Kabushiki Kaisha vs Aurobindo Pharma and Aurobindo Pharma USA Inc, Civil Action No 08-MD-01949].
Aurobindo now has a total of 116 ANDA approvals (86 final approvals and 30 tentative approvals) from the US FDA.