Barr receives approval for generic Mirapex tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

The Company is currently challenging a patent protecting Mirapex and a trial is scheduled to begin on March 10, 2008 in the District Court in Delaware. Under the terms of a Court Order, Barr has agreed not to launch its Pramipexole Dihydrochloride tablets product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.

Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. The Company received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the FDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.

Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

http://www.barrlabs.com/

Comments

  1. Schuyler Sharp Schuyler Sharp United States says:

    When is generic Mirapex going on the market?

  2. joe joe United States says:

    I have tried a generic Mirapex 2 weeks now, have suffered headaches each day but did not seem to have any problem using Mirapex?

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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