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PUREPAC's GEMFIBROZIL GAINS TENTATIVE APPROVAL

Executive Summary

PUREPAC's GEMFIBROZIL GAINS TENTATIVE APPROVAL Oct. 4, making the Kalipharma subsidiary the first company to get the agency's approval of a generic version of Warner-Lambert's Lopid. The tentative approval is for 300 mg gemfibrozil capsules, a dosage form discontinued by Warner-Lambert earlier this year. Warner- Lambert currently markets a 600 mg tablet of the cholesterol- lowering agent. Purepac says it has a generic version of the 600 mg dosage "in development." When Purepac filed its ANDA for gemfibrozil in 1988, Lopid's patent was set to expire July 4, 1989. However, in 1989, Warner- Lambert was granted a three-and-a-half year patent extension until Jan. 4, 1993. The generics firm is not challenging the Lopid patent and cannot begin marketing generic gemfibrozil until Lopid's patent expires. Lopid is Warner-Lambert's largest source of revenue, with $ 371 mil. in sales in 1990. The company plans to evergreen the drug by marketing an extended-release form, Lopid SR, for which the company filed an NDA in February of this year.
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