IntelGenx Corp. announced that the US Patent and Trademark Office (USPTO) has issued a formal Notice of Allowance 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 US Food and Drug Administration's (FDA) Orange Book.
"This Notice of Allowance demonstrates IntelGenx's ability to successfully develop and patent novel products through our proprietary VersaTab technology," said Dr. Horst G. Zerbe, president and chief executive officer of IntelGenx. "We believe CPI-300 could fill a significant need in the lucrative bupropion market. With the potential to be the first and only single-tablet high-dose form of bupropion HCl on the market, we believe CPI-300's convenience and patient compliance advantages could make it a very successful brand."
IntelGenx is currently awaiting approval from the FDA for its New Drug Application (NDA) for CPI-300. 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.
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems.