IntelGenx Corp. has announced that the U.S. Patent and Trademark Office issued patent number 7,674,479 on March 9, 2010 for a key patent application protecting IntelGenx’s CPI-300, a novel, high strength formulation of Bupropion hydrochloride (“HCl”), the active ingredient in Wellbutrin XL.
The patent entitled “Sustained-Release Bupropion and Bupropion/Mecamylamine Tablets” discloses the formulation of pharmaceutical tablets containing sustained-release granules of Bupropion HCl distributed in a sustained-release matrix. The patent will ultimately provide broad protection for CPI-300 until 2027 (twenty years from the filing date) and upon regulatory approval be listed in the U.S. Food and Drug Administration’s (“FDA”) Orange Book.
“The successful issuance of this patent provides formidable intellectual property protection for CPI-300 and further strengthens our competitive position in the substantial Bupropion market,” said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx.
IntelGenx recently received a complete response letter from FDA for its New Drug Application (“NDA”) for CPI-300, and is in the process of preparing an amendment to address the issues raised in the complete response letter. IntelGenx and Cary Pharmaceuticals entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx’s proprietary oral VersaTab delivery technology. Cary Pharmaceuticals serves as the NDA applicant for CPI-300.