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Natco制药达菲(Tamiflu)仿制药获FDA预批准

来源:生物谷 2014-03-18 18:08

2014年3月18日讯 /生物谷BIOON/ --印度仿制药生产商Natco制药(Natco Pharma)3月18日宣布,磷酸奥司他韦(Oseltamivir Phosphate,30mg,45mg,75mg)胶囊获得了FDA的预批准(tentative approval),该药是罗氏品牌药达菲(Tamiflu)的仿制药,是一种非常有效的流感治疗药物。

Natco可能会是首个获得简化新药申请(ANDA)批准的公司,这将赋予该公司在美国180天的市场独占权。目前,Natco已与美国Alvogen公司达成合作,计划在美国市场推出磷酸奥司他韦胶囊。

根据IMS Health数据,截止2013年9月,罗氏品牌药Tamiflu在美国的年销售额为4.95亿美元。

关于达菲(Tamiflu):

达菲(Tamiflu)是罗氏独家生产的抗流感药物,通用名称为磷酸奥司他韦(Oseltamivir phosphate)。奥司他韦(Oseltamivir)于1999年在瑞士上市,2001年10月在我国上市。达菲是一种非常有效的流感治疗用药,并且可以大大减少并发症(主要是气管炎与支气管炎、肺炎、咽炎等)的发生和抗生素的使用,因而是目前治疗流感的最常用药物之一,也是公认的抗禽流感、甲型H1N1流感最有效的药物之一。

奥司他韦口服后经肝脏和肠道酯酶迅速催化转化为其活性代谢物奥司他韦羧酸,奥司他韦羧酸的构型与神经氨酸的过渡态相似,能够竞争性地与流感病毒神经氨酸酶(NA,neu-raminidase,也有称作神经氨酸苷酶)的活动位点结合,因而是一种强效的高选择性的流感病毒NA抑制剂(NAIs),它主要通过干扰病毒从被感染的宿主细胞中释放,从而减少甲型或乙型流感病毒的传播。(生物谷Bioon.com)

英文原文:Natco gets tentative FDA nod to launch generic Tamiflu capsules in US

Natco gets tentative nod to launch the drug, Oseltamivir Phosphate, in capsules of 30mg, 45mg and 75mg dosage

Natco has partnered with US-based pharmaceutical company Alvogen to market the drug in the US. Photo: AFP
Hyderabad: Hyderabad-based Natco Pharma Ltd on Tuesday said it got has tentative approval from the US Food and Drug Administration (FDA) to launch a generic version of Swiss pharmaceutical firm Roche Holding AG’s Tamiflu, used to treat bird and swine flu.
Natco Pharma said it has tentative approval to launch the drug, Oseltamivir Phosphate, in capsules of 30mg, 45mg and 75mg dosage.
Natco has partnered with US-based pharmaceutical company Alvogen to market the drug in the US.
“Natco may have first-to-file approval status for the abbreviated new drug application (ANDA), contingent upon successful litigation outcome of orginal patent 5,763,483,” Natco said in a statement.
A first-to-file approval entitles a company to 180 days of marketing exclusivity in the US.
Tamiflu had US sales of around $495 million for the 12 months ended September 2013, according US healthcare information provider IMS Health.
Shares of Natco were up 1.4% to Rs.835.56 at 11.49am on BSE, while the benchmark Sensex gained 0.83% to 21,989.75 points.

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