St. Louis, MO – December 15, 2015 GeneriCo, LLC (GeneriCo) today announced that it has recently filed a petition for Inter Partes Review (IPR) of United States Patent No. 8,865,688 (the 688 patent) with the United States Patent and Trademark Office (USPTO).
The 688 patent, titled, Compositions and methods for treatment of bowel diseases with granulated mesalamine, currently provides AprisoÂ® (extended-release capsules containing 0.375g mesalamine and locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults) FDA Orange Book exclusivity through May 1, 2030. The additional patents listed in the FDA Orange Book for AprisoÂ® expire on April 20, 2018.
Along with our IPR partner Flat Line Capital, LLC, we look forward to rigorously reviewing the patentability of the claims in the 688 patent with the USPTO, explained Tom Brya, GeneriCo President and CEO. We seek to increase patient access to mesalamine treatments for ulcerative colitis and are utilizing the 688 IPR to obtain freedom-to-operate.
At this time, GeneriCo anticipates a USPTO IPR institution decision within approximately six months and a final ruling on the validity of the 688 patent 12 months thereafter. According to IMS Health data trends, annual U.S. sales of AprisoÂ® are approximately over $200 million annually.