Barr Pharma (BRL) Announces Favorable Ruling in Mirapex Patent Challenge
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Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that U.S. District Court for Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.
In his ruling, District Court Judge Joseph J. Farnan, Jr. found that the patent claims at issue in the litigation were invalid on the grounds of nonstatutory double patenting.
Barr's Abbreviated New Drug Application (ANDA) for a generic Mirapex product received final approval from the U.S. Food and Drug Administration (FDA) in February 2008. Barr believes that it is the first company to file an ANDA with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
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