Mylan granted restraining order against Apotex

PITTSBURGH — Mylan on Wednesday announced that U.S. District Court for the district of New Jersey granted a temporary restraining order against Apotex Inc. and Apotex Corp. relating to Paroxetine CR, the authorized generic version of Paxil CR from GlaxoSmithKline. The court ordered Apotex to immediately cease all sales and supply of Paroxetine CR.



Additionally, the court ordered Apotex to immediately recall all product that shipped since the injunction was entered on July 16.



Mylan holds an exclusive license to the Orange Book patent associated with Paxil CR, which expires July 2016, with pediatric exclusivity extending until Jan. 19, 2017, according to Mylan. The company believes its the only company to have filed an abbreviated new drug application for generic Paxil CR that contains a paragraph-IV certification. The court previously awarded a permanent injunction against GlaxoSmithKline in relation to generic Paxil CR.