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www.fdanews.com/articles/81458-barr-challenging-boehringer-s-mirapex-patent

BARR CHALLENGING BOEHRINGER'S MIRAPEX PATENT

October 6, 2005

Barr Pharmaceuticals has applied to market a generic version of Boehringer Ingelheim Pharmaceuticals' Parkinson's disease drug Mirapex.

Boehringer recently filed a lawsuit against Barr in the U.S. District Court for the District of Delaware to keep Barr from commercializing its version of the drug, according to Barr. Mirapex (pramipexole dihydrochloride), used to treat signs and symptoms of Parkinson's disease such as tremors and rigidity, generated sales of approximately $244 million in the twelve months ended July 2005, according to research firm IMS Health.

Barr, which wants to market pramipexole in 0.125-, 0.25-, 0.5-, 1- and 1.5-mg tablets, is challenging both of Boehringer's patents for Mirapex; one expires November 2007, the other March 2011. Barr filed its abbreviated new drug application with a Paragraph IV certification, aiming to win the 180-day exclusivity period awarded to the first generic company that challenges a listed drug patent.