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Court of Appeals Upholds FDA Award of Gabapentin Exclusivity to Alpharma

Law360 (January 20, 2004, 12:00 AM EST) -- The U.S. District Appeals Court for the District of Columbia rejected a challenge from generic drug maker Apotex and upheld rival Alpharma’s 180-day marketing exclusivity period for gabapentin capsules.

In January 2003, Alpharma said its subsidiary Purepac Pharmaceutical Co had received confirmation from the U.S. Food and Drug Administration that it had secured eligibility for 180 day market exclusivity on gabapentin 100 mg, 300 mg and 400 mg capsules.

Torpharm Inc., a subsidiary of Apotex, Inc. challenged this FDA decision in the District Court. The District...
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