Barr Gets FDA Nod for Generic Mirapex

Tuesday October 30, 11:54 am ET
http://biz.yahoo.com/ap/071030/barr_..._fda.html?.v=1

Barr Pharmaceuticals Gets FDA Tentative Marketing Approval for Generic Mirapex

WOODCLIFF LAKE, N.J. (AP) -- Barr Pharmaceuticals Inc. said Tuesday federal regulators granted tentative approval to its generic version of Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex tablets to treat Parkinson's disease.

The U.S. Food and Drug Administration issued tentative approval to the generic drug maker's abbreviated new drug application for pramipexole dihydrochloride tablets at 0.125 milligram, 0.25 milligram, 0.5 milligram, 1 milligram and 1.5 milligram dosages.

Boehringer Ingelheim Corp.'s subsidiary, Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals, makes Mirapex which is indicated for the treatment of Parkinson's disease.

Mirapex's patent begins facing expiry March 25, 2011, according to the FDA. Barr and Boehringer Ingelheim have been engaged in a patent dispute since 2005.

Barr said it filed an ANDA with a Paragraph IV patent certification in May 2005. A so-called Paragraph IV certification indicates that its generic drug would infringe an existing patent, but the company claims that the patent is not valid.

The patent challenge ensued after Barr notified Boehringer of its plans to market generic Mirapex. Barr said the trial scheduled for Nov. 5 was postponed. A new date has not been set.