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 provide broad protection for CPI-300 until 2027 (twenty years from the filing date) and upon regulatory approval be listed in the FDA Orange Book.
IntelGenx has 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.
Reportedly, IntelGenx and Cary Pharmaceuticals have entered into a collaborative agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx’s oral VersaTab delivery technology. Cary Pharmaceuticals serves as the NDA applicant for CPI-300.
Horst Zerbe, president and chief executive officer of IntelGenx, said: “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.”