SunGen Pharma receives seventh ANDA approval from US FDA


2019-09-09 12:04:45 PHARMACEUTICAL


The seventh approved ANDA is for Fosapreptant for Injection 150mg/vial. This drug product is used for treatment of cyclic vomiting syndrome and late-stage chemotherapy induced vomiting. This is a sub blockbuster product of over $350M US market size for 2018 according to IQVIA. RLD Emend’s orange book patent expired on Sep 4th and SunGen obtained its ANDA approval on Sep 5th, which makes it is the first wave of all generic approvals for RLD Emend. “This first wave generic approval right after RLD patent expiration represents another key milestone by our own team” said Dr. Isaac Liu, Co-Founder and Co-CEO of the company. “Our high quality development expertise are further demonstrated by the short approval timeline. It takes US FDA less than 10 months to approve this important ANDA.” SunGen Pharma started its oral and topical research and development center in January 2016. In August 2016, it entered into a Development and License Agreement with Elite Pharmaceuticals, Inc. to collaborate to develop and commercialize four generic pharmaceutical products. SunGen formed a sales and marketing joint venture with Athenex Pharmaceuticals in September 2016 named Peterson Athenex Pharmaceuticals to market seven pharmaceutical products. SunGen established its injectable division in October 2017 through the acquisition of a privately held pharmaceutical company based in Monmouth Junction, New Jersey. The company launched its first injectable product, Terbutaline Sulfate, as a prefilled liquid vial with a strength of 1mg/1ml. The product was launched July 10th, 2017. In August 2018, SunGen announced it has entered into a strategic manufacturing partnership with Grand River Aseptic Manufacturing to collaborate in the manufacturing and commercialization of generic injectable pharmaceutical products. SunGen and its partners acquired Busulfan injectable ANDA from Sandoz in October 2018 and launched the product into US hospitals in March 2019. In June 2019, SunGen Pharma announces to launch Bivalirudin through PIV Challenges in US, in partnership with Athenex and Hainan Shuangcheng Pharmaceuticals. Source: Company Press Release
第七个批准的 ANDA 用于注射用Fosapreptant 150mg /瓶。本品用于治疗周期性呕吐综合征和晚期化疗所致呕吐。根据 IQVIA 的数据,这是2018年美国市场规模超过3.5亿美元的次级重磅产品。RLD Emend 的橙皮书专利于9月4日到期, SunGen 于9月5日获得 ANDA 批准,使其成为 RLD Emend 所有仿制药批准的第一波。 “ RLD 专利到期后的第一波仿制药批准是我们团队的另一个重要里程碑,”公司联合创始人兼联合首席执行官 IsaacLiu 博士说。“短期批准时间表进一步证明了我们高质量的开发专业知识。美国 FDA 需要不到10个月的时间来批准这一重要的 ANDA 。” SunGen Pharma 于2016年1月启动口服及外用研发中心。 2016年8月,与 Elite Pharmaceuticals , Inc .签订《开发许可协议》,合作开发和商业化4个仿制药产品。 SunGen 于2016年9月与 Athenex Pharmaceuticals 组建了一家销售和营销合资公司,名称为 Peterson Athenex Pharmaceuticals ,销售七种医药产品。 SunGen 于2017年10月通过收购位于新泽西州 Monmouth Junction 的一家私人控股制药公司,成立了注射剂事业部。该公司推出了其第一个注射用产品特布他林硫酸钠,作为预填充液体小瓶,强度为1mg /1ml 。该产品于2017年7月10日上市。 2018年8月, SunGen 宣布与 Grand River Asptic Manufacturing 达成战略制造合作伙伴关系,合作生产和商业化仿制药注射剂产品。 SunGen 及其合作伙伴于2018年10月从 Sandoz 公司收购了 Busulban 注射用 ANDA ,并于2019年3月将该产品投放美国医院。 2019年6月, SunGen Pharma 宣布与 Athenex 和海南双成药业合作,通过 PIV 挑战赛在美国推出比伐卢定。 资料来源:公司新闻稿