打开APP

迈兰推出Focalin XR仿制药

  1. Focalin XR
  2. 多动症
  3. 迈兰

来源:生物谷 2013-11-20 09:10

迈兰推出盐酸右哌甲酯缓释胶囊,该药是诺华Focalin XR的首个仿制药,用于6岁及以上注意缺陷与多动障碍(ADHD)患者的治疗。

2013年11月19日讯 /生物谷BIOON/ --迈兰(Mylan)11月18日宣布,旗下子公司迈兰制药(Mylan Pharmaceuticals)推出盐酸右哌甲酯缓释胶囊(Dexmethylphenidate HCl ER,30mg),该药是诺华(Novartis)Focalin XR(dexmethylphenidate HCl XR,盐酸右哌甲酯缓释胶囊)的首个仿制药,用于6岁及以上注意缺陷与多动障碍(ADHD)患者的治疗。

Mylan是首个提交包含盐酸右哌甲酯缓释胶囊(30mg)Paragraph IV专利认证的简化新药申请(ANDA)的公司,在FDA批准该药ANDA的同时,获得了180天的市场独占权。

根据IMS数据,截止2013年9月30日,Focalin XR的年销售额为6700万美元。(生物谷Bioon.com)

英文原文:Mylan Launches First Generic Focalin XR? Capsules, 30 mg

- Company awarded 180 days marketing exclusivity -

PITTSBURGH, Nov. 18, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Dexmethylphenidate Hydrochloride Extended-release (ER) Capsules, 30 mg, which is the first generic version of Novartis' Focalin XR?. Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for Dexmethylphenidate Hydrochloride ER Capsules, 30 mg. The company received final approval from the U.S. Food and Drug Administration (FDA) for its ANDA for this product and was awarded 180 days of marketing exclusivity.

According to IMS Health, Dexmethylphenidate Hydrochloride ER Capsules, 30 mg, had U.S. sales of approximately $67.34 million for the 12 months ending Sept. 30, 2013. This product is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients age 6 years and older.

Currently, Mylan has 179 ANDAs pending FDA approval representing $90.5 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according toIMS Health.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->