Barr Pharma announced that U.S. District Court for Delaware has invalidated the Orange Book listed product patent of innovator Boehringer Ingelheim's Mirapex Tablets (Pramipexole Dihydrochloride) 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
Barr successfully invalidated US4886812 (product patent) protecting Mirapex in the District Court in Delaware. In a significant ruling, District Court Judge opined that the product claim in litigation are invalid because of double patenting.
Earlier, Barr received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the USFDA, 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.
Also, in Feb 2008, Barr got final approval on its ANDA but decided to launch the 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.
Now Barr with First Para IV filing exclusivity can immediately launch its product in US market and other generics can also enter by the end of this year or in the first half of 2009 i.e after the expiry of 180 days FTF exclusivity of Barr.
Pramipexole was approved by USFDA on July 1, 1997. Barr has got final approval on February 19, 2008 and Mylan has got Tentative approval on May 8, 2007. Earlier, innovator has also sued Mylan for '812 parent
IP pharma Doc has earlier reported about trial on this case here
