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人福医药:奥卡西平缓释片获得美国 FDA 暂定批准文号

Core Viewpoint - The announcement indicates that Renfu Pharmaceutical's subsidiary, Renfu Likang Pharmaceutical Co., Ltd., has received a tentative approval number from the FDA for Oxcarbazepine extended-release tablets, which are intended for the treatment of partial seizures in patients aged 6 and above [1] Group 1: Product Development - Renfu Likang has invested approximately 15 million RMB in the research and development of Oxcarbazepine extended-release tablets [1] - The total sales revenue for Oxcarbazepine extended-release tablets in the U.S. market is projected to be around 216 million USD in 2024 [1] Group 2: Patent and Market Entry - Supernus currently holds the patent for Oxcarbazepine extended-release tablets, which is set to expire on April 13, 2027 [1] - Renfu Likang can only launch the product in the U.S. market after the patent expiration and the final approval from the FDA [1]