POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicines that transform lives, today announced that it has filed a motion for a preliminary injunction seeking to prevent Par Pharmaceuticals, Inc. (Par) from launching a generic version of Treximet® (sumatriptan and naproxen sodium). Par, which POZEN believes has 180 days of exclusivity for its generic product as the first company to file an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA), could launch the product into the United States market, at risk, after regulatory exclusivity for Treximet expires on April 15, 2011. The motion was filed in the United States District Court for the Eastern District of Texas, where the Company's ongoing patent litigation against Par and several other generic companies is pending. There can be no assurance that the motion will be granted.
The Company has three issued U.S. patents covering Treximet which are licensed exclusively to GlaxoSmithKline (GSK) in the United States, two of which expire in August 2017 and one which expires in October 2025, which have been challenged by four generic companies who have filed ANDAs with FDA seeking approval to market generic versions of the product. The Company filed suit against Par, Alphapharm Pty Ltd., ("Alphapharm"), Teva Pharmaceuticals USA ("Teva"), and Dr. Reddy's Laboratories, Inc. ("Dr. Reddy's"), all in the United States District Court for the Eastern District of Texas, and the cases were consolidated into one suit. A settlement was reached with Teva in April 2010. The case against Par, Alphapharm and Dr. Reddy's was tried before Judge Leonard Davis in October 2010. A decision in the case is pending.
POZEN continues to have full confidence in the strength of its intellectual property rights protecting Treximet and will continue to vigorously defend and enforce its intellectual property.
Source: POZEN
波曾公司（NASDAQ：POZN），一家制药公司，致力于改变个人的生命转化的药品，今天宣布，它已经提交了一项动议Treximet版本的初步禁令（杆）由发射一个通用寻求预防，制药公司的帕®（舒马普坦和萘普生钠）。帕，这波曾认为有180其作为第一家将文件与美国食品和药物管理局（FDA）的简化新药申请（ANDA）通用产品独占天，可以启动进入美国市场的产品，在风险，对2011年4月15日之后，监管排他性的Treximet到期。该议案被提交在美国地区法院在德克萨斯州东区，本公司的抗PAR和其他一些通用公司正在进行的专利诉讼仍悬而未决。不可能有任何议案将被授予保证。
本公司已发行有三个美国专利许可覆盖Treximet是完全）在美国葛兰素史克（GSK，其中两个仿制药申请2017年八月届满一年十月是在2025年到期，这一般由四家公司受到挑战已经向谁寻求与FDA批准上市的产品的仿制药。本公司向抗PAR，Alphapharm私人有限公司（“Alphapharm”），Teva药厂美国（“Teva公司”）西装，雷迪博士实验室公司（“雷迪博士”），所有在美国地区法院在德克萨斯州东部地区，而合并为一宗诉讼。获得解决，达成了Teva公司在2010年4月。对帕，Alphapharm和雷迪博士的案件是法官伦纳德戴维斯尝试过在2010年10月。在对案件作出裁决。