Appeals Court Affirms Rights to Exclusive Sales of Generic Zocor

By William Murphy

Published on November 17, 2006

In affirming the lower court's decision, the appeals court agreed that the U.S. Food and Drug Administration had wrongfully denied Israel's Teva Pharmaceuticals and India's Ranbaxy Laboratories an exclusive six-month period to market their generic versions of drug maker Merck's popular anti-cholesterol drug Zocor. The first generic-drug manufacturer to file with U.S. regulators after a patent expires typically is awarded six months of exclusive marketing rights. Both companies launched sales of their generic versions of Zocor in June 2006, the same month Merck's U.S. patent on Zocor expired.

The FDA complied with the initial ruling, which granted Teva and Ranbaxy the exclusive marketing period, but appealed based on its policy that a generic-drug manufacturer must be sued by a brand-name competitor to qualify for exclusivity. The appeals court ruled that the FDA's policy violated federal law pertaining to generic drugs and acted as a disincentive to introducing generic drugs.

A Ranbaxy spokesman applauded the appeals court's decision as benefiting Ranbaxy and the entire generic drug industry.

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