Novartis’ generic unit, Sandoz, Inc., has filed a complaint against Teva Pharmaceutical Industries in the U.S. District Court for the District of Columbia, for seeking approval of its generic Zocor products following an April 30, 2006 decision of the same Court.

The decision in April granted Teva’s motion for summary judgment on the issue of whether its ANDA to market a generic version of Merck’s Zocor is entitled to 180-day Hatch-Waxman statutory exclusivity. The Court found unlawful the FDA’s October 24, 2005 decision denying a citizen’s petition on the exclusivity issue and, accordingly, remanded the matter back to the FDA, which has since appealed to the U.S. Court of Appeals.

Teva is eligible to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, 2006, when the product patent expires.

Sandoz has asked the Court to order the FDA not to approve Teva’s generic Zocor products pending a determination of its motion for a preliminary injunction ordering the FDA to approve Sandoz’s ANDA. A hearing has been scheduled for this morning.