Teva, Cephalon Sue FDA Over Generic Provigil Exclusivity

Law360, Chicago (April 4, 2012, 5:25 PM EDT) -- Teva Pharmaceuticals USA Inc. and Cephalon Inc. sued the U.S. Food and Drug Administration in Washington federal court Tuesday seeking to bar the agency from robbing Teva of the marketing exclusivity period they say it earned through patent certifications for its generic version of Cephalon's blockbuster sleep disorder drug Provigil.

Cephalon — a wholly owned, indirect subsidiary of Teva Ltd. — and Teva allege that despite the 180-day exclusivity period Teva is entitled to thanks to the patent certifications included in the abbreviated new drug application...
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