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Report: Court OKs agreement between GSK, Apotex over generic Paxil CR

NEW YORK — GlaxoSmithKline can sell an authorized generic of its antidepressant drug to Toronto-based drug maker Apotex, a U.S. judge ruled.

According to a Bloomberg Businessweek report, U.S. District Court judge Joe Pisano ruled the agreement was valid.

In 2008, generic drug maker Mylan entered an agreement with GSK to launch a generic version of Paxil CR. In September 2010, Mylan obtained a temporary restraining order against Apotex when the latter launched its generic version of the drug. One month later, a U.S. District Court denied a motion for a preliminary injunction filed by Mylan to prevent Apotex from making a generic version of the antidepressant drug.

“The language plainly states that GSK may commence marketing and selling of authorized generic Paxil CR after Mylan’s two-year period of exclusivity,” Pisano ruled. “GSK did exactly that. It marketed and sold authorized generic Paxil CR to Apotex.”


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