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12/7/2012 7:54:04 AM
The Swiss drug maker Novartis had been bracing all year for the day in late September when Diovan, its top-selling blood pressure drug, would lose patent protection and a cheaper generic version would become available. But September has come and gone, and now, nearly three months later, there is still no generic alternative to Diovan on the market. The Food and Drug Administration has not given final clearance to Ranbaxy, the generic drug maker that won the exclusive right to sell the drug for the first six months after its patent expired. Now a competing generic company, Mylan, is suing the F.D.A. to force the agency to revoke Ranbaxy’s exclusive rights and allow Mylan to begin selling the drug. A hearing on the matter is scheduled for Friday in federal court in Washington. Mylan is exclusively selling a related drug, a combination of Diovan and a diuretic, whose patent protection also expired in September. The delay in approval of generic Diovan has proved to be an unexpected bright spot for Novartis, since Diovan brought in more than $1.9 billion in United States sales last year, according to the health care research firm IMS Health. “It’s like extra cash,” said Kim Vukhac, an analyst for Crédit Agricole.
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