Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) submitted to the US FDA via the 505(b)(2) route for its paliperidone palmitate extended-release injectable suspension (LY03010) has not faced a patent infringement lawsuit in the US. This follows the FDA’s acceptance of the application for review and the expiration of the litigation time limit as specified in the Food and Drug Act. The drug is seeking approval for the treatment of schizophrenia and schizophrenic affective disorder, and it obtained a US patent last year, which is valid through 2039.
After submitting the NDA for LY03010 to the FDA, Luye Pharma issued a fourth paragraph patent declaration (Paragraph IV) to the marketing authorization holder (MAH) and patent holder of INVEGA SUSTENNA, Janssen Pharmaceuticals. According to the Food and Drug Act, MAHs and patent holders are required to file a lawsuit within 45 days of receiving the fourth paragraph patent declaration to initiate a 30-month review suspension period.
As of the announcement’s date, the litigation period that would have triggered a 30-month approval stay has expired without any legal action being taken against Luye Pharma. Consequently, LY03010 faces no patent hurdles in the FDA’s NDA review process, with the Prescription Drug User Fee Act (PDUFA) date set for July 26, 2024.- Flcube.com
