Barr Pharmaceuticals, Inc. today 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(R) 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.
Barr Receives Final Approval for Generic Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
Barr Receives Final Approval for Generic Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
Following patents are listed in orange book for Pramipexole Dihydrochloride Tablets
US4886812 (Expiry: MAR 25,2011)- Product patent (specific)
US6001861 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
US6194445 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
The Company is currently challenging US4886812 (product 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.
Mylan has also filed ANDA and innovator has sued Mylan also for the infringement of US4886812. Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
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.
Mylan has also filed ANDA and innovator has sued Mylan also for the infringement of US4886812. Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
