Teva Pharmaceutical Industries Ltd. announced that it had strongly disagreed on US Food and Drug Administration action regarding the 180-day exclusivity period applicable to ANDAs for generic Pravastatin Sodium Tablets 10 mg., 20 mg., 40 mg., and 80 mg, the generic equivalents of Pravachol.

The FDA has decided that any 180-day exclusivity period arising from US Patents Nos. 5,030,447, 5,180,589, and 5,622,985 began to run on August 22, 2004, the date the order dismissing a declaratory judgment action suit by Apotex Inc. against Bristol-Myers Squibb Co. became final. This decision is based upon the FDA’s interpretation of prior case law.

According to the company release, Teva believes that there are significant distinctions between the facts surrounding the Pravastatin dismissal and the prior case law. Teva will immediately pursue legal action to obtain reversal of the decision. As the first applicant to file an ANDA under Paragraph IV of Hatch-Waxman Act, Teva continues to believe that it is entitled to 180 days of marketing exclusivity for generic Pravastatin Sodium Tablets 10 mg., 20 mg., and 40 mg.

Israel Makov, Teva’s President and CEO said: “Although we are disappointed by this ruling which we intend to strongly oppose, we are confident that Teva’s portfolio of new generic products will contribute to significant growth during 2006 and 2007, a period during which we expect to launch approximately 80 generic products in the US.”