St. Louis, MO June 13, 2016 GeneriCo, LLC (GeneriCo), a global specialty generic drug company, today announced it has received a favorable institution decision for its 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 as a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults) FDA Orange Book exclusivity through May 1, 2030.
Tom Brya, GeneriCo President and CEO, stated Along with our IPR partner Flat Line Capital, LLC, we seek to increase patient access to mesalamine treatments for ulcerative colitis and are utilizing the 688 IPR to obtain freedom-to-operate. Because other patents listed in the FDA Orange Book for AprisoÂ® expire on April 20, 2018, GeneriCo will, upon the successful completion of the IPR, have freedom to provide patients with an alternative equivalent medication prescribed by their doctor a dozen years earlier while also opening the market to further generic competition.
We welcome this USPTO IPR institution decision and are confident this action will lead to a final ruling nullifying the 688 Patent, said Kevin Barnes, Principal of Flat Line Capital, LLC. We will continue to aggressively press forward with GeneriCo on the development and commercialization of the mesalamine treatment consistent with our corporate strategies.
According to Symphony Health Solutions, annual U.S. sales of AprisoÂ® exceed $200 million.
GeneriCo is global generic pharmaceutical company within significant specialty segments of the rapidly growing U.S. generic drug market. The St. Louis co-founder team of industry experts have over 200 years of combined experience, a global footprint, and is driven to bring difficult-to-make generic drugs to the U.S. markets deploying a unique collaborator strategy. The Company’s expertise and global network allows it to create generic products while avoiding expensive investment in all aspects of drug development. The team has serial successes in the targeted markets with over $1B sales in generic drug launches. GeneriCo’s product pipeline currently includes over 40 potential drug formulations and contract distribution rights for several additional drugs, as well as several potential Paragraph IV challenge opportunities. For more information, please visit www.genericopharma.com
Daniel Thompson, COO
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