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Apotex Victory in Generic Paxil® Case Confirmed Once Again
Federal
Appeals Court Affirms District Court’s Judgment in Favor of Apotex
Weston,
FL (April 11, 2005) —Apotex Corp. today announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Apotex holding, for the second time, that the asserted claim of GlaxoSmithKline’s U.S. Patent No. 4,721,723 for the antidepressant Paxil® (paroxetine hydrochloride) is invalid.
“We are extremely pleased with this decision,” said Apotex Chief Executive Officer Barry Sherman. “The appeals court has once again ruled in our favor, proving what we have sustained for years: Apotex’ paroxetine does not infringe any valid patents, and we will continue to offer this affordable drug to our customers,” Dr. Sherman said.
In 1998, Apotex submitted to the FDA the first application to manufacture and supply generic Paxil®. Subsequent to that application, GSK filed nine additional patents with FDA, leading to additional infringement lawsuits. Apotex launched its paroxetine product in September 2003, after receiving final FDA approval. U.S. annual sales of paroxetine hydrochloride tablets are approximately $880 million.
The Apotex Group manufactures more than 50 different high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions.
Paxil® is a registered trademark of GlaxoSmithKline.
About Apotex Corp.
Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of generic pharmaceuticals. Through its sales and marketing headquarters in Weston, Florida, operations center in Indianapolis, and research facility in Lincolnshire, Illinois, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit
apotexcorp.com.
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