人福醫藥(600079.SH):磷酸奧司他韋膠囊獲得美國FDA批准文號
格隆匯10月8日丨人福醫藥(600079.SH)公佈,近日,公司全資子公司Epic Pharma, LLC(簡稱“Epic Pharma”)收到美國食品藥品監督管理局(FDA)關於磷酸奧司他韋膠囊的批准文號。
磷酸奧司他韋膠囊用於成人和1歲及1歲以上兒童的甲型和乙型流感治療和成人及13歲(含13歲)以上青少年的甲型和乙型流感的預防。Epic Pharma於2020年提交磷酸奧司他韋膠囊的ANDA申請,累計研發投入約為140萬美元。
根據IQVIA數據統計,2020年該藥品在美國市場的總銷售額約為1.4億美元,主要生產廠商包括Amneal、Lupin等。根據米內網數據統計,2020年度奧司他韋所有劑型在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為27億元人民幣,主要生產廠商為宜昌東陽光長江藥業股份有限公司、Roche Pharma(Schweiz) AG、上海中西三維藥業有限公司等。
該次磷酸奧司他韋膠囊獲得美國FDA批准文號標誌着Epic Pharma具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響,公司後續將積極推進該產品在美國市場的上市準備工作。
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