FDA Approves Three Generic Versions of Merck Statin Zocor

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Journal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).