医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Litigation Judgment Removes A Major Hurdle For Esomeprazole Strontium Delayed-Release Capsules from Hanmi and Marketing Partner Amneal

2013年06月05日 AM01:25
このエントリーをはてなブックマークに追加


 

SEOUL, Korea

Hanmi Pharmaceutical Company Limited and Amneal Pharmaceuticals, LLC announced today that, pursuant to a confidential settlement agreement, a consent judgment has been entered by the United States District Court for the District of New Jersey with respect to the ongoing patent infringement litigation between Hanmi and AstraZeneca PLC involving Hanmi’s proposal to market esomeprazole strontium delayed release capsules. AstraZeneca originally filed suit in February of 2011 alleging that Hanmi’s product infringed two AstraZeneca patents involving its heartburn drug, Nexium®.

The consent judgment provides that (1) Hanmi has acknowledged that the two asserted patents are enforceable and valid, and (2) the Hanmi product does not infringe the claims of the two asserted patents based upon the claim construction ruling issued by the District Court on December 12, 2012. Although AstraZeneca has reserved its right to appeal the District Court’s claim construction, Hanmi believes that the District Court’s claim construction ruling is sound and, accordingly, Hanmi’s non-infringement position is on solid ground.

Hanmi’s product obtained tentative FDA approval on April 30, 2013. Hanmi and its marketing partner, Amneal Pharmaceuticals LLC, anticipate receiving final FDA approval shortly. Hanmi’s product would be the first non-innovator pharmaceutical product commercialized in the United States that contains the active moiety esomeprazole. Hanmi would also be the first Korean company to enter the United States market under the Hatch-Waxman statutory framework.

CONTACT

Media Relations contact:
Cheryl Lechok Communications, LLC
Cheryl
Lechok, +1 203-613-1506
clechok@optonline.net

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • サラダックス・バイオメディカル、サルバトーレ・J・サラモネ博士が権威ある C.E. Pippenger博士賞を受賞したと発表
  • Japan’s MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer
  • VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan
  • TAE Life Sciences Announces Installation of First Accelerator-based Neutron Beam System for Biologically Targeted Radiation Therapy at Xiamen Humanity Hospital in China
  • New Study Evaluates the Feasibility of Using Masimo EMMA® Capnography on Mechanically Ventilated Neonates