Teva closer to launching generic Pravachol after court rejects Apotex injunction

By Angela McDaniels

Seattle, April 19 - Teva Pharmaceutical Industries Ltd. said the U.S. District Court for the District of Columbia has denied Apotex Inc.'s motion for a temporary restraining order and preliminary injunction against Teva's 180 days of marketing exclusivity for the first generic version of Bristol-Myers Squibb's Pravachol (pravastatin sodium) tablets in the United States.

At Apotex's request, the court ordered the Food and Drug Administration to refrain from issuing a final approval for Teva's Abbreviated New Drug Application for generic pravastatin 10, 20 and 40 mg strengths until after 5 p.m. on Friday in order to give Apotex time to appeal the ruling.

Teva had expected to receive final approval with exclusivity when the patent on the cholesterol-lowering drug expires on Thursday, according to a company news release.

On April 12, the FDA denied Apotex's request for an agency determination that 180-day exclusivity for pravastatin 10, 20 and 40 mg had been triggered and run.

Teva Pharmaceutical is based in Jerusalem, Israel, and develops, manufactures and markets generic pharmaceuticals and active pharmaceutical ingredients.

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