Judge Upholds FDA Rule On Market Exclusivity

Law360, New York (February 14, 2006, 12:00 AM EST) -- Although the generic form of popular heartburn drug Prilosec is available in 10 milligram and 20 milligram doses, generic drug makers are still fighting tooth and nail for the right to produce a 40 milligram dose. A judge has denied Canadian-based Apotex permission to market a 40 mg dose of the drug, upholding competitor Andrx’s rights to 180 days of market exclusivity.

Andrx was the first company to file an Abbreviated New Drug Application for the 40 mg dose, and the Food and Drug Administration granted...
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