Mylan Wins Motion for Temporary Restraining Order Against Apotex for Authorized Generic of Paxil® CR District Court Judge Orders Apotex to Immediately Recall the Authorized Generic from its Direct Customers and to Stop Selling and Supplying the Product

PITTSBURGH, July 23, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the District of New Jersey granted its motion for a temporary restraining order against Apotex Inc. and Apotex Corporation in litigation relating to Paroxetine CR, the authorized generic of GlaxoSmithKline's Paxil® CR. The District Court ordered Apotex to immediately discontinue all sales and supply of Paroxetine CR. Mylan previously obtained an order enjoining GlaxoSmithKline from supplying Paroxetine CR to Apotex. 

In addition, the District Court ordered Apotex to immediately recall all product from its direct customers that was shipped since the injunction was entered on July 16, 2014. 

Mylan has an exclusive license to an Orange Book patent pertaining to Paxil CR which expires in July 2016, with pediatric exclusivity extending until Jan. 19, 2017. Mylan further believes that it is the only company to have filed an abbreviated new drug application for generic Paxil CR that contains a paragraph IV certification.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

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SOURCE Mylan Inc.



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