Mylan Granted Temporary Restraining Order Against Apotex

Mylan Inc.reports hat the US 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 that expires in July 2016, with pediatric exclusivity extending until January 19, 2017. Mylan said it 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.

Source: Mylan


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