Teva Loses Pravachol Exclusivity Period; Multiple Generics To Launch In 2006

FDA tells Teva that the 180-day exclusivity period for three pravastatin doses expired in February. As a result, as many as six companies – including Teva – could be in a position to launch generic Pravachol when Bristol’s composition of matter patent expires in April 2006. Teva plans to sue FDA to reinstate its first-to-file exclusivity period.