Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex (Pramipexole Dihydrochloride) tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 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.
Barr filed its Abbreviated New Drug Application (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 US 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.
Although trial of the case had been scheduled for November 5, 2007, due to a judicial vacancy in the District Court, the trial is not expected to commence then. A new trial date has not been set. The 30-month stay expires on or about February 15, 2008.
Mirapex (Pramipexole Dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The product had annual sales of approximately $324 million for the twelve months ended August 2007, based on IMS sales data.
A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries.